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

NCT03057574 | Unknown Phase 4 DMC

• 1 other identifier: r-hFSH13082013
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (3)

• 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: * Good * Clear cytoplasm/normal shape * Single distinct polar body * Clear/thin zona pellucida * Fair * Slightly grainy cytoplasm/misshapen * Fragmented/abnormal polar body * Slightly pigmented/amorphous zona * Cytoplasmic bodies * PV (vitelline platelets) debris * Poor * Dark/grainy cytoplasm/misshapen * \>1 polar body structure * Pigmented/thickened zona * Vacuoles * PV (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 Outcomes (5)

• Eventual AE/SAEs related to the administration of Gonapure®

  50 days after baseline visit (EOS)

• Total & Mean Gonapure ® Daily Dose

  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

  50 days after baseline visit (EOS)

• Number of Participants with Ovarian Hyperstimulation Syndrome

  50 days after baseline visit (EOS)

Study Arms (1)

Treatment

EXPERIMENTAL

Follitropin Alfa (Gonapure)

Drug: Follitropin Alfa

Interventions

Follitropin Alfa DRUG

Patients must be prescribed Follitropin Alfa (Gonapure®)

Also known as: Gonapure ®

Treatment

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects aged between 18 and 38 years.
• Female subjects with body mass index (BMI) ≥ 18 and ≤ 40 kilogram per square meter (kg/m\^2)
• Female subjects with basal FSH less than 10 IU/L and PRL serum values within the normal range in the early follicular phase.
• Female subjects having both ovaries.
• Female subjects with normal uterine cavity, which in the investigator's opinion is compatible with pregnancy.
• 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.
• Female subjects who are willing and able to comply with the protocol for the duration of the trial
• 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.

You may not qualify if:

• 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.
• Female subjects with uterine myoma requiring treatment.
• Female subjects with any contraindication of being pregnant and/or carrying a pregnancy to term.
• Female subjects with history of tumors of the hypothalamus and pituitary gland.
• Female subjects with history of ovarian, uterine or mammary cancer.
• Female subjects with history of hypersensitivity to the active substance follitropin alpha, FSH, or to any of the excipients of Gonapure ®.
• Female subjects with untreated hydrosalpinx diagnosed by U/S.
• Female subjects with abnormal gynecological bleeding of unknown etiology.
• 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.

Sponsors & Collaborators

• MinaPharm Pharmaceuticals: lead

Study Sites (2)

Alexandria University

Alexandria, Egypt

RECRUITING

Ain Shams University

Cairo, Egypt

COMPLETED

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashraf Kortam, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Kortam, PhD

CONTACT

+201001433714; oeissa@minapharm.com

Emad Khalefa, PhD

CONTACT

oeissa@minapharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: February 20, 2017
• Study Start: February 9, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)