Clinical trial NCT03057574: Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Female Infertility
Lead sponsor: MinaPharm Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of oocytes retrieved on the day of Ovum Pick-Up
timeFrame: 50 days after baseline visit (EOS)
measure: Number of Mature Oocytes (MII) Retrieved Per Participant
timeFrame: 50 days after baseline visit (EOS)
measure: Quality of Oocytes Retrieved per participant
timeFrame: 50 days after baseline visit (EOS)
Secondary outcomes:
measure: Eventual AE/SAEs related to the administration of Gonapure®
timeFrame: 50 days after baseline visit (EOS)
measure: Total & Mean Gonapure ® Daily Dose
timeFrame: 14 days
measure: Number of follicles ≥ 18 mm on day of administration of hCG
timeFrame: 50 days after baseline visit (EOS)
measure: Number of Participants with Multiple Pregnancies
timeFrame: 50 days after baseline visit (EOS)
measure: Number of Participants with Ovarian Hyperstimulation Syndrome
timeFrame: 50 days after baseline visit (EOS)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ashraf Kortam, PhD
role: PRINCIPAL_INVESTIGATOR
References: