Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT02381184|
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : August 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: clomiphene citrate Procedure: laparoscopic ovarian drilling (LOD)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Clomiphene Citrate Regimen Versus Laparoscopic Ovarian Drilling for Ovulation Induction in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Active Comparator: Clomiphene Citrate group (Group A)
Group A (n =68) assigned to receive100 mg of clomiphene citrate (Clomid®; Hoechst Marion Russel, Cairo, Egypt) daily starting on day 3 of spontaneous or progestin induced cycle for 10 days.
Drug: clomiphene citrate
receive100 mg of clomiphene citrate (Clomid®; Hoechst Marion Russel, Cairo, Egypt) daily starting on day 3 of spontaneous or progestin induced cycle for 10 days.
Other Name: Clomid
Active Comparator: laparoscopic ovarian drilling (LOD) Group B
Group B (n =68) underwent LOD. Laparoscopy was performed under general anesthesia, using three-puncture technique. Each ovary was cauterized perpendicular to its antimesenteric border at four points, each for 4 seconds at 40 W with a mixed current, using a monopolar electrosurgical needle (Karl Storz, ND, Germany). Each puncture was about 4 mm in diameter and 6-8 mm in depth. The ovary was cooled by irrigation with normal saline solution. Any, intraoperative or postoperative complication was reported. The follow-up was started from the next cycle after ovarian drilling up to 6 months
Procedure: laparoscopic ovarian drilling (LOD)
Laparoscopy was performed under general anesthesia, using three-puncture technique
- the ovulation rate [ Time Frame: midluteal (day 21of the cycle) ]serum progesterone was ≥ 5 ng/mL.
- the endometrial thickness [ Time Frame: the day of the hCG injection ]Sonographic of endometrial thickness
- the rates of clinical pregnancy [ Time Frame: 2 weeks after HCG injection ]Serum β-hCG is determined Sonographic evidence of an intrauterine gestational sac at 6 weeks gestation was considered an evident of a clinical pregnancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381184
|Benha Faculty of Medicine|
|Benha, El Qaluobia, Egypt, 13518|
|Principal Investigator:||ahmed morad||assistant professor|
|Study Chair:||khalid mohamed||lecturer|