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Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381184
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: clomiphene citrate Procedure: laparoscopic ovarian drilling (LOD) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the ovulation rate [ Time Frame: midluteal (day 21of the cycle) ]
    serum progesterone was ≥ 5 ng/mL.


Secondary Outcome Measures :
  1. the endometrial thickness [ Time Frame: the day of the hCG injection ]
    Sonographic of endometrial thickness

  2. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Egypt
Benha Faculty of Medicine
Benha, El Qaluobia, Egypt, 13518
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: ahmed morad assistant professor
Study Chair: khalid mohamed lecturer
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Responsible Party: khalid abd aziz mohamed, principal investigator, Benha University
ClinicalTrials.gov Identifier: NCT02381184    
Other Study ID Numbers: khalid-walid
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators