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

NCT05362799 | Unknown Phase 4 DMC

• 1 other identifier: 3/2022/OBG
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (3)

• Occurrence of ovulation

  US detection of one or more follicles of 18mm or more

  18 month

• Number of dominant follicles

  US detection of follicles \>18mm

  18 month

• Endometrial thickness

  US assessment of endometrial thickness

  18 months

Secondary Outcomes (7)

• Occurrence of pregnancy which will be subdivided into: chemical pregnancy or clinical pregnancy

  18 months

• Total number of patients getting pregnant after each treatment cycle in each group

  18 months

• Number of cycles cancelled in each group

  18 months

• Number of patients developing OHSS in each group

  18 months

• Number of patients having multiple pregnancy in each group

  18 months

Study Arms (4)

GROUP 1

ACTIVE COMPARATOR

GROUP 1: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days.

Drug: Letrozol (Femara, Novartis)

GROUP 2

ACTIVE COMPARATOR

GROUP 2: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test

Drug: Letrozol (Femara, Novartis) combined with Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt)

GROUP 3

ACTIVE COMPARATOR

Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry.

Drug: highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland)

GROUP 4

ACTIVE COMPARATOR

Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test

Drug: highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) combined with metformin

Interventions

Letrozol (Femara, Novartis) DRUG

Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days.

GROUP 1

Letrozol (Femara, Novartis) combined with Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) DRUG

Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test

GROUP 2

highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) DRUG

Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry.

GROUP 3

highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) combined with metformin DRUG

Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test

GROUP 4

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged between 20-35 years
• Body mass index ≤ 30
• 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)
• 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)
• Failure to achieve pregnancy after 3 cycles of ultrasound indicated ovulation with clomiphene citrate treatment at a dose of 100mg or 150mg daily.
• Day-2 follicle-stimulating hormone less than 12 IU/ml
• Normal serum prolactin and thyroid function
• Normal uterine cavity
• At least one patent tube
• Male partner with normal semen count and motility according to WHO criteria

You may not qualify if:

• Male factor infertility
• Bilateral tubal block
• Uncontrolled thyroid dysfunction
• Uterine factor of infertility.
• Known cases with endometriosis.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Infertility, Female

Interventions

Letrozole; lactitol; Metformin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share