Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome

NCT02381184 | Completed Phase 2

• 1 other identifier: khalid-walid
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days) for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical pregnancy and abortion.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• the ovulation rate

  serum progesterone was ≥ 5 ng/mL.

  midluteal (day 21of the cycle)

Secondary Outcomes (2)

• the endometrial thickness

  the day of the hCG injection

• the rates of clinical pregnancy

  2 weeks after HCG injection

Study Arms (2)

Clomiphene Citrate group (Group A)

ACTIVE COMPARATOR

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

laparoscopic ovarian drilling (LOD) Group B

ACTIVE COMPARATOR

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)

Interventions

clomiphene citrate DRUG

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.

Also known as: Clomid

Clomiphene Citrate group (Group A)

laparoscopic ovarian drilling (LOD) PROCEDURE

Laparoscopy was performed under general anesthesia, using three-puncture technique

laparoscopic ovarian drilling (LOD) Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: between 18-35 years
• Period of infertility \> 2 years
• Serum level of FSH \<10 U/L in the early follicular phase
• All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles
• All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO criteria

You may not qualify if:

• Infertility due to causes other than CC- resistant PCOS or due to combined factors
• Body mass index (BMI) ≥35 Kg/m²
• The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months
• Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function
• Hypersensitivity or contraindications to Letrozole or clomiphene treatment
• Previous LOD

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Faculty of Medicine

Banhā, El Qaluobia, 13518, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• ahmed morad

  assistant professor

  PRINCIPAL INVESTIGATOR

• khalid mohamed

  lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: March 6, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

EG (1)