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

Summary

Participation Requirements

Description

This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam. Women who are potentially eligible will be provided information about the trial as long as their stimulation cycles are initiated. Screening for eligibility will be performed by treating physicians on day 2 of the menstrual...

This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam. Women who are potentially eligible will be provided information about the trial as long as their stimulation cycles are initiated. Screening for eligibility will be performed by treating physicians on day 2 of the menstrual cycle in the subsequent frozen embryo transfer cycles. Patients will be provided a copy of the informed consent documents. Written informed consent is going to be obtained by the investigator from all women before the enrolment. Women will be randomized (1:1:1) to AC (artificial cycle) or NC (natural cycle) or mNC (modified natural cycle) protocols using block randomization with a variable block size of 6 or 9 by an independent study coordinator via telephone, using a computer-generated random list (block size of 6, or 9). Artificial protocol The endometrium is prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 8 mg/day, ranging from the second or fourth menstruation day. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Utrogestan®; Besins) 800 mg/day will be initiated when endometrial thickness reaches ?7 mm. Estradiol exposure must be lasting for ?9 days before progesterone administration. Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages. In cases where a dominant follicle emerged, serum LH and progesterone will be determined to rule out luteinization. If LH concentrations are <13 IU and progesterone levels <7 nmol/l, luteinization will deem not to have occurred, and FET was performed. Natural protocol The first ultrasound scan will be performed on the second to the fourth day of the menstrual cycle to identify any problem related to the patients' uterus or adnexa. The second ultrasound will be performed on the sixth day of the cycle. Daily ultrasound and serum estradiol and LH level evaluation will be performed when the mean diameter of the dominant follicle of ?14 mm. LH surge initiation is defined as a concentration of 180% above the latest serum value available in that patient with a continued rise thereafter9 to a level of 20 IU/l or more10 detected by the ECLIA method (Roche Cobas® E 801, Roche Diagnostics, Germany). Embryo transfer will be scheduled by the time of the initiation of LH and embryo stages. modified Natural protocol The first ultrasound scan will be performed on the second to the fourth day of the menstrual cycle to identify any problem related to patients' uterus or adnexa. A second ultrasound scan will be performed on the sixth day of the cycle; if there is at least one follicle with a diameter of ?12 mm, an ultrasound scan will be performed daily. When the dominant follicle's mean diameter is ?16 mm, human chorionic gonadotropin - hCG (Ovitrelle® 250 ?g; Merck, Kenilworth, NJ, USA) will be injected to trigger ovulation. Embryo transfer will be scheduled by the time of the hCG injection and embryo stages. Cycle cancellation Artificial protocol: When the endometrial thickness is below 7mm after a duration of estradiol administration of ?21 days or the emerging of a dominant follicle. Natural cycle protocol: When there is no onset of LH surge observed after a duration of ?21 days. modified Natural cycle protocol: When there is no dominant follicle with a diameter of 16mm emerged after a duration of ?21 days. Both protocols: When there is no embryo survived after thawing. Frozen embryo transfer A maximum of 2 day-3 and one day-5 embryo will be thawed on the day of embryo transfer, three days after the start of progesterone. Two hours after thawing, surviving embryos will be transferred into the uterus under ultrasound guidance using a soft uterine catheter (Gynétics®, Belgium). A series of progesterone levels evaluation will be performed at three times: (1) The start of the cycle, (2) Before the time the embryo transfer is scheduled, (3) On the day of embryo transfer. The blood sample at the start of the cycle will be stored for further epigenetics analysis. Future babies' health will also be performed separately.

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