LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anovulation
- Polycystic Ovary Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Description
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PC...
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment. Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations. For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options . Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple pregnancies with LOD . Giving these advantages together with being cheap, the surgical strategy may be a more favorable choice as second line treatment of anovulation . Also several randomised controlled trial (RCTs) reported normalization of ovarian reserve parameters after LOD, making it a long-lasting option compared to the one-cycle effect of medical treatment the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
Tracking Information
- NCT #
- NCT04325295
- Collaborators
- Not Provided
- Investigators
- Study Director: Sayed A Abdallah Professor of obstetric and Gynecology,Faculty of Medicine,Assuit University O Study Director: Essam R Othman Assistant Professor of Obstetrics and Gynecology,Faculty of Medicine, Assuit University Study Director: Mustafa B Mohammed Assistant professor of Obstetrics and Gynecology, Faculty of Medicine,Assuit University Study Director: Ahmed M Alaa Eldin Lecturer of Obstetrics and Gynecology,Faculty of Medicine,Assuit University Study Director: Karim S Abdallah Assistant lecturer of Obstetrics and Gynecology,Faculty of Medicine,Assuit University
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