Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for female subjects with infertility Undergoing IVF/ICSI

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MinaPharm Pharmaceuticals
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

1. Female subjects aged between 18 and 38 years.

2. Female subjects with body mass index (BMI) ≥ 18 and ≤ 40 kilogram per square meter (kg/m^2)

3. Female subjects with basal FSH less than 10 IU/L and PRL serum values within the normal range in the early follicular phase.

4. Female subjects having both ovaries.

5. Female subjects with normal uterine cavity, which in the investigator's opinion is compatible with pregnancy.

6. Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy.

7. Female subjects who are willing and able to comply with the protocol for the duration of the trial

8. Female subjects who have given written informed consent, prior to any trial-related procedure, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.

Exclusion Criteria:

1. Female subjects with any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug.

2. Female subjects with uterine myoma requiring treatment.

3. Female subjects with any contraindication of being pregnant and/or carrying a pregnancy to term.

4. Female subjects with history of tumors of the hypothalamus and pituitary gland.

5. Female subjects with history of ovarian, uterine or mammary cancer.

6. Female subjects with history of hypersensitivity to the active substance follitropin alpha, FSH, or to any of the excipients of Gonapure ®.

7. Female subjects with untreated hydrosalpinx diagnosed by U/S.

8. Female subjects with abnormal gynecological bleeding of unknown etiology.

9. Female subjects with any medical condition which, in the opinion of the investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy.