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

Primary Purpose

Female Infertility

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Follitropin Alfa

About this trial

This is an interventional treatment trial for Female Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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have given written informed consent, prior to any trial-related procedure, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.

Exclusion Criteria:

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.

Sites / Locations

Alexandria UniversityRecruiting
Ain Shams University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Follitropin Alfa (Gonapure)

Outcomes

Primary Outcome Measures

Number of oocytes retrieved on the day of Ovum Pick-Up

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.

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.

Secondary Outcome Measures

Eventual AE/SAEs related to the administration of Gonapure®

Total & Mean Gonapure ® Daily Dose

Time Frame: Start of treatment until end of stimulation cycle

Number of follicles ≥ 18 mm on day of administration of hCG

Number of Participants with Multiple Pregnancies

Multiple pregnancies were defined as 2 or more fetal hearts with activity.

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.

Full Information

NCT ID

NCT03057574

First Posted

November 30, 2016

Last Updated

August 29, 2017

Sponsor

MinaPharm Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03057574

Brief Title

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

Acronym

GIVF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 9, 2017 (Actual)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MinaPharm Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Follitropin Alfa (Gonapure)

Intervention Type

Drug

Intervention Name(s)

Follitropin Alfa

Other Intervention Name(s)

Gonapure ®

Intervention Description

Patients must be prescribed Follitropin Alfa (Gonapure®)

Primary Outcome Measure Information:

Title

Number of oocytes retrieved on the day of Ovum Pick-Up

Time Frame

50 days after baseline visit (EOS)

Title

Number of Mature Oocytes (MII) Retrieved Per Participant

Description

Time Frame

50 days after baseline visit (EOS)

Title

Quality of Oocytes Retrieved per participant

Description

Time Frame

50 days after baseline visit (EOS)

Secondary Outcome Measure Information:

Title

Eventual AE/SAEs related to the administration of Gonapure®

Time Frame

50 days after baseline visit (EOS)

Title

Total & Mean Gonapure ® Daily Dose

Description

Time Frame: Start of treatment until end of stimulation cycle

Time Frame

14 days

Title

Number of follicles ≥ 18 mm on day of administration of hCG

Time Frame

50 days after baseline visit (EOS)

Title

Number of Participants with Multiple Pregnancies

Description

Multiple pregnancies were defined as 2 or more fetal hearts with activity.

Time Frame

50 days after baseline visit (EOS)

Title

Number of Participants with Ovarian Hyperstimulation Syndrome

Description

OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid Accumulation, hemoconcentration, and increased blood clotting.

Time Frame

50 days after baseline visit (EOS)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashraf Kortam, PhD

Phone

+201001433714

oeissa@minapharm.com

First Name & Middle Initial & Last Name or Official Title & Degree

Emad Khalefa, PhD

oeissa@minapharm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashraf Kortam, PhD

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria University

City

Alexandria

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emad Khalefa, PhD

Facility Name

Ain Shams University

City

Cairo

Country

Egypt

Individual Site Status

Completed

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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