Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI (GIVF)

An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI

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

Study Overview

• Status: Unknown
• Conditions: Female Infertility
• Intervention / Treatment: Drug: Follitropin Alfa

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: Emad Khalefa, PhD
  • Cairo, Egypt
    • Completed
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Follitropin Alfa (Gonapure)	Drug: Follitropin Alfa; Patients must be prescribed Follitropin Alfa (Gonapure®); Other Names: Gonapure ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved on the day of Ovum Pick-Up		50 days after baseline visit (EOS)
Number of Mature Oocytes (MII) Retrieved Per Participant	Metaphase II (MII): The oocyte is in the second phase of meiosis and is mature. Oocytes at this stage of maturity are ready for fertilization. Mean number of Mature oocytes (MII) retrieved on the day of ovum pick up (OPU) will be calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.	50 days after baseline visit (EOS)
Quality of Oocytes Retrieved per participant	It is graded on a good-fair-poor scale: GoodClear cytoplasm/normal shapeSingle distinct polar bodyClear/thin zona pellucida; Fair; Slightly grainy cytoplasm/misshapen; Fragmented/abnormal polar body; Slightly pigmented/amorphous zona; Cytoplasmic bodies; PV (vitelline platelets) debris; PoorDark/grainy cytoplasm/misshapen>1 polar body structurePigmented/thickened zonaVacuolesPV (vitelline platelets) debris; Good Quality embryos per participant. Those embryos that have reached the most advanced developmental stage and have the least cellular fragmentation (Grades "A" and/or "B") will be considered Good Quality embryos and will be selected for transfer.; Number of transferred embryos per participant.; Percentage of Participants with Clinical Pregnancy. Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan.	50 days after baseline visit (EOS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eventual AE/SAEs related to the administration of Gonapure®		50 days after baseline visit (EOS)
Total & Mean Gonapure ® Daily Dose	Time Frame: Start of treatment until end of stimulation cycle	14 days
Number of follicles ≥ 18 mm on day of administration of hCG		50 days after baseline visit (EOS)
Number of Participants with Multiple Pregnancies	Multiple pregnancies were defined as 2 or more fetal hearts with activity.	50 days after baseline visit (EOS)
Number of Participants with Ovarian Hyperstimulation Syndrome	OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid Accumulation, hemoconcentration, and increased blood clotting.	50 days after baseline visit (EOS)

Collaborators and Investigators

• Sponsor: MinaPharm Pharmaceuticals
• Investigators: Principal Investigator: Ashraf Kortam, PhD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: r-hFSH13082013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No