Different Induction Protocols in PCOS After Clomiphene Citrate Failed Pregnancy in Non-IVF Cycles

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study will be to compare between 4 different induction protocols in women who:

1. Failed to achieve ovulation after clomiphene citrate treatment at a dose of 150mg daily (if the patient can tolerate this dose) for 5 days for 3 cycles or only 100 mg daily for the same duration (if she can't tolerate higher dose)

2. Failed to achieve pregnancy after 3 cycles of ultrasound indicated ovulation with clomiphene citrate treatment at a dose of 100mg or 150mg daily.

All induction protocols will be carried out in non-IVF cycles, and continued for 3 cycles or until pregnancy whichever will be earlier.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Menoufia University
• Treatments: Lactitol; Letrozole; Metformin

Criteria

Inclusion Criteria:

1. Women aged between 20-35 years

2. Body mass index ≤ 30

3. Primary or secondary infertility for ≥1 year due to PCOS (diagnosed based on Rotterdam criteria which require the presence of two of the following: Oligo\an ovulation , hyperandrogenism, polycystic ovaries on ultrasound)

4. Failure to achieve ovulation after clomiphene citrate treatment at a dose of 150mg daily (if the patient can tolerate this dose) for 5 days for 3 cycles or only 100 mg daily for the same duration (if she can't tolerate higher dose)

5. Failure to achieve pregnancy after 3 cycles of ultrasound indicated ovulation with clomiphene citrate treatment at a dose of 100mg or 150mg daily.

6. Day-2 follicle-stimulating hormone less than 12 IU/ml

7. Normal serum prolactin and thyroid function

8. Normal uterine cavity

9. At least one patent tube

10. Male partner with normal semen count and motility according to WHO criteria

Exclusion Criteria:

1. Male factor infertility

2. Bilateral tubal block

3. Uncontrolled thyroid dysfunction

4. Uterine factor of infertility.

5. Known cases with endometriosis.