Status:
COMPLETED
Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance
Lead Sponsor:
Saudi German Hospital - Madinah
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
PHASE3
Brief Summary
Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant...
Detailed Description
Patients were divided randomly into two groups (A and B), who underwent controlled ovarian stimulation and timed intercourse, using random table computer software (Open Epi version 3.21). Basal trans...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with Clomiphene Citrate resistant PCOS who fulfilled the following inclusion criteria:
- Age 18 to 35 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m2
- Presenting with primary or secondary infertility.
- PCOS was diagnosed according to the Rotterdam ESHRE/ASRM Consensus workshop, with at least 2 of the following 3 criteria:
- A- Oligo- and/or anovulation; manifested by oligomenorrhea or amenorrhea. Oligomenorrhea was defined as cycle interval of more than 35 days but less than six months. Amenorrhea was defined as absence of menstruation for six months or more.
- B- Hyperandrogenism; biochemical and/or clinical in the form of acne or hirsutism defined as a score of 8 or higher using the modified Ferriman-Gallwey scoring system when abnormal hair distribution was assessed in nine body areas and given a score of 0 to 4.
- C - Polycystic ovarian morphology detected by transvaginal ultrasound with the presence of 12 or more follicles measuring 2-9 mm in diameter in one or both ovaries, and/or increased ovarian volume \>10 mL.
- Clomiphene Citrate resistance was defined as failure of ovulation after administration of Clomiphene Citrate in a dose of 150 mg for 5 days per cycle, for two or three cycles.
- Patent both fallopian tubes and normal uterine cavity as evidenced by hysterosalpingography (HSG).
- Their partners had normal semen parameters as defined by the modified WHO 2010 criteria.
- Exclusion criteria were:
- Morbidly obese patients with BMI ≥35 Kg/2m.
- Abnormal husband semen analysis.
- Abnormal HSG or laparoscopic evidence of pelvic adhesions.
- Patients receiving statin drugs for cholesterol, beta-blockers for high blood pressure, or tricyclic antidepressants, were also excluded as these drugs can lower the levels of ubiquinol in the body.
Exclusion
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04870502
Start Date
April 1 2019
End Date
July 31 2020
Last Update
May 3 2021
Active Locations (1)
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1
Saudi German Hospital
Al Madīnah, Madinah, Saudi Arabia, 41311