Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: Female

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 PCOS patients.

Methods: 148 PCOS Patients with Clomiphene Citrate resistance were randomized into two groups (A and B). In group A, controlled ovarian stimulation was done by Clomiphene Citrate 150 mg daily (from 2nd till 6th day of cycle) together with Ubiquinol starting from 2nd day till day of hCG triggering in a dose of 100 mg orally once daily. In group B, hMG was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU. Serial transvaginal ultrasonography was done starting on cycle day 8 and continued till size of leading follicle reaches 18 mm or more then ovulation triggering was done. Thereafter, patients were advised for a timed intercourse (TI) after 36 hours. A blood sample was withdrawn seven days after hCG triggering, for measurement of serum progesterone. If the Patient presented with a missed period for one week, a serum sample was sent for β-hCG.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Saudi German Hospital - Madinah
• Treatments: Clomiphene; Enclomiphene; Zuclomiphene

Criteria

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.