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

NCT ID: NCT03057574

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-09
• Study Completion Date: 2018-01-31

Brief Summary

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

Detailed Description

Gonapure® is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin and contains no luteinizing hormone (LH) activity.

FSH stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Gonapure® is the primary hormone responsible for follicular recruitment and development. In order to affect final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of FSH, when monitoring of the patient indicates that sufficient follicular development has occurred. There is inter-patient variability in response to FSH administration.

The dosage and schedule of treatment for female infertility must be determined according to the needs of each patient; it is usual to monitor response by studying the patient's serum oestrogen level and/or by ultrasonic visualization of follicles.

Treatment should be started within the first 7 days of the menstrual cycle. Treatment is usually begun with 75 to 450 International units daily by intramuscular injection for 7 to 10 days; followed by individual adjustments according to the patient's follicular response i.e. until an adequate, but not excessive, response is achieved.

The investigator will decide the starting dose according to the standard clinical practice (and within the approved label).

Treatment is then stopped and followed after 1 or 2 days by a single dose of human chorionic Gonadotropin 10000 International units to induce oocyte maturation.

Conditions

Female Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Follitropin Alfa (Gonapure)

Group Type: EXPERIMENTAL

Follitropin Alfa

Intervention Type: DRUG

Patients must be prescribed Follitropin Alfa (Gonapure®)

Interventions

Follitropin Alfa

Patients must be prescribed Follitropin Alfa (Gonapure®)

Intervention Type: DRUG

Other Intervention Names

Gonapure ®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MinaPharm Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashraf Kortam, PhD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Ain Shams University

Cairo, , Egypt

Site Status: COMPLETED

Countries

Egypt

Central Contacts

Ashraf Kortam, PhD

Role: CONTACT

oeissa@minapharm.com

+201001433714

Emad Khalefa, PhD

Role: CONTACT

oeissa@minapharm.com

Facility Contacts

Emad Khalefa, PhD

Role: primary

Other Identifiers

r-hFSH13082013

Identifier Type: -

Identifier Source: org_study_id