Polycystic Ovarian Syndrome (PCOS), Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Conditions
Keywords
Clomiphene Citrate, Sildenafil Citrate, Ovulation Induction, Pregnancy, Polycystic Ovarian Syndrome, Endometrial Thickness, Subfertility
Brief summary
The goal of this randomized clinical trial is to compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with sildenafil citrate for inducing ovulation and achieving pregnancy in women with polycystic ovary syndrome (PCOS) who have difficulty becoming pregnant. The main question the study aims to answer is: Does adding sildenafil citrate to clomiphene citrate increase the chance of ovulation and pregnancy compared with clomiphene citrate alone in women with PCOS? The study will include 98 women aged 18-45 years with PCOS and a history of difficulty achieving pregnancy for more than 2 years. Participants will be randomly assigned to one of two groups. * Participants in Group A will receive clomiphene citrate 100 mg once daily from days 3-7 of the menstrual cycle, plus sildenafil citrate 25 mg twice daily from days 8-12. * Participants in Group B will receive clomiphene citrate 100 mg once daily from days 3-7, plus a placebo twice daily from days 8-12. Treatment will be given for 12 weeks. Participants will be assessed for ovulation, pregnancy, and endometrial thickness. Ovulation will be assessed using transvaginal ultrasound and/or a blood progesterone test. Pregnancy will be assessed using a urine pregnancy test and/or ultrasound. The primary hypothesis is that women receiving clomiphene citrate plus sildenafil citrate will have a higher rate of pregnancy than women receiving clomiphene citrate alone. The study will also determine whether adding sildenafil improves ovulation and endometrial thickness.
Interventions
Clomiphene citrate 100 mg administered orally once daily from menstrual cycle days 3-7 for ovulation induction. Treatment will be repeated for 12 weeks.
Sildenafil citrate 25 mg administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate, for ovulation induction. Treatment will be repeated for 12 weeks.
DRUGPlacebo
Matching placebo containing starch administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate. Treatment will be repeated for 12 weeks.
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women with PCOS, * Sub-fertility attributed to PCOS, \> 2 years
Exclusion criteria
* Comorbidities; diabetes, hypertension * Chronic medical illness (liver, heart, kidney disease) * Undergone ovarian drilling * Recent administration of hormonal therapy * Abnormal prolactin levels (\>500 mIU/L), or thyroid function tests (TSH \>5.2 mIU/L, T3 \<70 ng/dl and T4 \<5.2 μg/dl) * Obstructed fallopian tubes documented on hysterosalpingography and * Abnormal semen analysis of their partners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks | Pregnancy will be considered achieved when a urine human chorionic gonadotropin (hCG) test is positive after 7 days of a missed menstrual period and/or a gestational sac is detected by ultrasound. |
Countries
Pakistan
Contacts
STUDY_CHAIRHajira M Associate Professor, FCPS
Nishtar Medical University
Outcome results
None listed