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48 active trials for IVF

Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.

Start: March 2021

Natural Cycle vs. Modified Natural Cycle vs. Artificial Cycle Protocol for Endometrial Preparation.

Fresh embryo transfer is a routine procedure in vitro fertilization (IVF) treatment. Since the first live birth after an IVF-FET (frozen embryo transfer), recent years have seen a dramatic rise in the number of FET cycles. Three endometrial preparation protocols for frozen-thawed embryo transfer, including artificial, natural, modified natural protocol, have been studied and applied to maximize treatment outcomes. However, those methods are being applied empirically as their efficacy and safety are yet to be determined. The objective of this study is to compare the effectiveness and safety of those protocols.

Start: March 2021

RCT to Assess the Impact of Microbiome Status in Infertile IVF Patients at Their First IVF/ICSI Cycle

Although the endometrium has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. The uterine microbiome can be defined as Lactobacillus-dominated (<90% Lactobacillus spp.) or non-Lactobacillus-dominated (<90% Lactobacillus spp. with >10% of other bacteria). The presence of a pathogenic microbiota in endometrium was associated with significant decrease in implantation, pregnancy, ongoing pregnancy and live birth rates. Some of these pathogens microorganisms can also produce infection and inflammation that may lead to chronic endometritis. Nowadays, the endometrial microbiome can be investigated with the EMMA test and the most known pathogens related with chronic endometritis can be detected with the ALICE test,both of them developed by Igenomix group. Our goal in this project is to investigate at what extent, if any, the analysis of the endometrial factor, at a microbiome level, in patients at their first IVF cycle improves their clinical outcome.

Start: April 2021

Follicular Fluid Raman Shifts and IVF Outcomes

This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.

Start: June 2019

Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles

This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.

Start: May 2019

Analysis of the Composition of the Vaginal Microbiota During IVF Treatment and Correlation With Serum Progesterone Level on the Day of Embryo Transfer

The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.

Start: April 2021

Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?

Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Start: January 2019

Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed. Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF Eligible women will be randomised into one of the two groups: Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger. There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles. The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.

Start: April 2020

Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF

In patients with oligospermia in the ejaculate or previous ICSI failures if it concurs with high DNA fragmentation, it has been hypothesized that the use of sperm obtained from the testicle would improve the clinical results, since a source of damage to the spermatic DNA is post-testicular in its storage in the epididymis and thus could be avoided. The clinical information available so far is low, of low quality and all the studies present certain limitations susceptible to improvements in further investigations before giving a definitive answer to patients in these circumstances, about whether they should opt for testicular biopsy or for the use of semen in the ejaculate.The intention proposed in our project, is to demonstrate whether using testicular sperm, compared to those available in an ejaculate in these cases, offers a clinically and statistically significant increase in chromosomally normal embryos available that may lead to better reproductive performance of the cycles, in a design never before done, where half of a patient's oocytes are inseminated from ejaculated sperm and the other half from sperm obtained in the testicular biopsy.

Start: October 2020

Health in Childhood Following Assisted Reproductive Technology

The purpose of this trial is to investigate the metabolic and cardiovascular health in children aged 6-8 years born after in-vitro fertilization with frozen embryo transfer

Start: January 2019

A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation

This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI

Start: February 2021

Effect of GM-CSF on CAPA-IVM System Success Rates in PCOS

In-vitro maturation (IVM) of human oocytes obtained from minimally stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the conventional Assisted Reproductive Technology (ART) treatment with controlled ovarian hyperstimulation (COH). However, maturation rate and the total blastocyst yield in oocytes undergoing in vitro maturation are still limited. This pilot study aims to evaluate the addition of an important growth factor known as Granulocyte macrophage colony stimulating factor (GM-CSF). The investigators hypothesize that the addition of GM-CSF to human IVM culture media will increase pregnancy rates to comparable levels to that of IVF, making it a viable clinical option for couples undergoing assisted reproductive treatment.

Start: March 2021

Higher Dose of Rekovelle in Oocyte Donors

Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.

Start: March 2021

The SMART Clinic: a Feasibility Study

This is a study of the feasibility of a translational research clinic for pregnancies conceived by in vitro fertilisation (IVF). A group of at least 120 pregnancies (of which, at least 80 IVF-conceived) will be followed from early pregnancy to delivery, in order to gain early insights into the growth of the baby before birth, the physical and emotional adaptation of the mother to the pregnancy and how the placenta works. The investigators will collect preliminary data on how these factors may differ between pregnancies conceived with and without IVF, and between different IVF treatment modalities such as fresh or "frozen" embryo transfer IVF. The study aims to understand the practicalities of such a clinic, to identify barriers to participation in the clinic, to assess the uptake of different research measurements and to identify key measurements/time points with the greatest potential to identify and understand the origin of fetal growth and maternal adaptation differences after IVF conception in a full scale study.

Start: March 2021

Effects of E2, P4 and LH Levels on the Day of Transfer and Endometrial Cavity Thickness on Implantation Success in Patients With Frozen-thawed Embryo Transfer Cycle

Thanks to recent advances in clinical practice and laboratory, embryo cryopreservation has become the first-line procedure in assisted reproductive technology. Embryo freezing process; Prevention of ovarian hyperstimulation syndrome is becoming an accepted practice for a growing number of indications, including preimplantation genetic testing (PGT), late follicular phase progesterone elevation, and embryo-endometrial asynchrony. Progesterone; plays a key role in the preparation of the endometrial cavity for embryo attachment. Supplementary progesterone preparations can be used to prevent luteal phase defects and provide progesterone support during cycle preparations for frozen-thawed embryo transfer. Our aim in this study is to show the effect of serum progesterone level on pregnancy outcomes on the day of embryo transfer.

Start: February 2021

Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.

Start: May 2020

Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.

To examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for IVF or intracytoplasmatic sperm injection (ICSI).

Start: September 2019

Immediate Versus Postponed Single Blastocyst Transfer in mNC-FET

The purpose of this randomized controlled trial is to investigate if immediate single blastocyst transfer (in the first menstrual cycle following oocyte retrieval) is non-inferior to standard postponed single blastocyst transfer (in the second or subsequent menstrual cycle following oocyte retrieval) in modified natural cycle frozen-thawed embryo transfer (mNC-FET) in terms of live birth rate.

Start: March 2021

Optimization of Frozen Embryo Transfers by Studying Progesterone on the Day of Transfer

The number of embryo transfers after freezing has increased over the last 10 years due to improvements in embryo freezing techniques and in particular the development of vitrification. This has also been made possible by changes in clinical protocols favouring freezing in patients at high risk of hyperstimulation and by different methods of endometrial preparation to receive embryos after rewarming. In fact, embryo transfer requires endometrial preparation to make implantation possible. There are various protocols for endometrial preparation. Endometrial preparations in the natural cycle, with or without induction of ovulation by FSH, require more regular monitoring, and allow the development of a main follicle that will give a corpus luteum that will secrete progesterone in the luteal phase, which can be supported by the supply of exogenous progesterone. In contrast, endometrial preparations in hormone replacement therapy (HRT) cycles are done by administering estradiol orally or transdermally to stimulate endometrial growth while blocking the patient's gonadotropic axis, and administering progesterone in the luteal phase to differentiate the endometrium. This preparation has the advantage of being simpler to monitor and organize. There is currently no consensus on a type of preparation that would give better results, and although the literature seems to show that there would be more miscarriages in a substituted cycle, there does not seem to be any difference in the birth rate per cycle in the end, whatever the type of endometrial preparation. Some teams have shown that in HRT, there appears to be more miscarriage when the progesterone level measured on the day of the frozen embryo transfer is lower, especially below a threshold of 9ng/mL. Labarta showed ESHRE in July 2019 that modifying the endometrial preparation if the progesterone level is below 9ng/mL on the day of transfer by adding subcutaneous progesterone (Progiron) resulted in a lower miscarriage rate, comparable to the usual miscarriage rates in spontaneous pregnancy. Thus, if the miscarriage rate is higher in HRT than in the natural cycle, and if this is related to "luteal insufficiency" characterized by a lower circulating serum progesterone level, the hypothesis of this study in the investigator's population would be that the serum progesterone level on the day of the frozen embryo transfer would be lower in HRT than in the spontaneous cycle.

Start: March 2020

Desogestrel Versus GnRH Antagonist in IVF/ICSI

Progestin primed ovarian stimulation (PPOS) has been shown to be effective in avoiding premature spontaneous ovulation, without affecting the number of retrieved oocytes or the quality of the embryos obtained. The utilization of progestins permits lower costs, an easier administration (oral assumption instead of injections) and a tight control over LH levels. Hence the PPOS may be a valid alternative to the standard ovarian stimulation protocols. Additionally, it may be anticipated some degree of superiority of PPOS in particular categories of patients: donors, women at risk of OHSS, women who preserve their as well as poor responder or suboptimal responders for whom oocytes/embryo accumulation or double ovarian stimulation protocols are proposed The aim of this trial will be to investigate the use of Desogestrel in controlling the LH surge during ovarian stimulation in IVF/ICSI cycles. This study is a noninferiority trial in which the the primary efficacy endpoint will be the number of oocytes retrieved per patient. Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate. A total of 165 patients will be included in this study Patients will be assigned to either the study or the control group. The study group will be administered follitropin alfa (Bemfola 150-225 IU/die) and Desogestrel (Cerazette 75 mcg daily ) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) and Ganirelix (Orgalutran 0.25 mg/die) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin 0.2 mg + hCG 1000 U s.c. Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. Viable embryos will be then frozen by means of vitrificaton on the day in which they will reach the blastocyst developmental stage.

Start: October 2020