Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: clomiphene citrate; Drug: Coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT01910766

CoQ10

Details and patient eligibility

About

Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.

Full description

No more details

Enrollment: 110 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
• All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium <5 mm at the time of hCG administration

Exclusion criteria

• patients with hyperprolactinaemia,
• hypercorticism and
• thyroid dysfunction.
• patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Coenzyme Q10/CC group

Experimental group

Description:

Intervention: Coenzyme Q10 (CoQ10) and clomiphene citrate group (55 patients, 82 cycles) Patients in CoQ10/CC group took CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6, and CoQ10 Mepaco, Enshas Elraml, Sharkhia, Egypt), in a dose of 60 mg 3 times day capsules orally starting on cycle day 2 and continued till the day of human chorionic gonadotropin (hCG) administration

Treatment:

Drug: Coenzyme Q10

Drug: clomiphene citrate

CC alone group

Active Comparator group

Description:

Intervention: CC (Global Napi, Cairo, Egypt) 100 mg/day from cycle days 2-6

Treatment:

Drug: clomiphene citrate