LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial 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 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04325295
Study type	Interventional
Source	Assiut University
Contact	Khaled M Attyia
Phone	+201005503250
Email	khaled.hussien@med.aun.edu.eg
Status	Not yet recruiting
Phase	N/A
Start date	December 2020
Completion date	August 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed	`NCT06158932` - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Completed	`NCT04932070` - Berberine and Polycystic Ovary Syndrome	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT03480022` - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS	Phase 3
Active, not recruiting	`NCT03043924` - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT05246306` - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed	`NCT05981742` - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	Phase 2
Completed	`NCT05702957` - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome	Phase 2/Phase 3
Completed	`NCT05029492` - Effect of Visceral Manipulation on PCOS	N/A
Completed	`NCT02924025` - Motivational Interviewing as an Intervention for PCOS	N/A
Not yet recruiting	`NCT02255578` - Endobarrier Treatment in Women With PCOS	Phase 3
Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
Withdrawn	`NCT01638988` - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin	Phase 3
Completed	`NCT02098668` - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	N/A
Completed	`NCT01462864` - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome	N/A
Recruiting	`NCT01431352` - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT00989781` - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome	N/A