Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI (GIVF)
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|ClinicalTrials.gov Identifier: NCT03057574|
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Female Infertility||Drug: Follitropin Alfa||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI|
|Actual Study Start Date :||February 9, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Follitropin Alfa (Gonapure)
Drug: Follitropin Alfa
Patients must be prescribed Follitropin Alfa (Gonapure®)
Other Name: Gonapure ®
- Number of oocytes retrieved on the day of Ovum Pick-Up [ Time Frame: 50 days after baseline visit (EOS) ]
- Number of Mature Oocytes (MII) Retrieved Per Participant [ Time Frame: 50 days after baseline visit (EOS) ]
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 [ Time Frame: 50 days after baseline visit (EOS) ]
It is graded on a good-fair-poor scale:
- Clear cytoplasm/normal shape
- Single distinct polar body
- Clear/thin zona pellucida
- Slightly grainy cytoplasm/misshapen
- Fragmented/abnormal polar body
- Slightly pigmented/amorphous zona
- Cytoplasmic bodies
- PV (vitelline platelets) debris
- Dark/grainy cytoplasm/misshapen
- >1 polar body structure
- Pigmented/thickened zona
- 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.
- Eventual AE/SAEs related to the administration of Gonapure® [ Time Frame: 50 days after baseline visit (EOS) ]
- Total & Mean Gonapure ® Daily Dose [ Time Frame: 14 days ]Time Frame: Start of treatment until end of stimulation cycle
- Number of follicles ≥ 18 mm on day of administration of hCG [ Time Frame: 50 days after baseline visit (EOS) ]
- Number of Participants with Multiple Pregnancies [ Time Frame: 50 days after baseline visit (EOS) ]Multiple pregnancies were defined as 2 or more fetal hearts with activity.
- Number of Participants with Ovarian Hyperstimulation Syndrome [ Time Frame: 50 days after baseline visit (EOS) ]OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid Accumulation, hemoconcentration, and increased blood clotting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057574
|Contact: Ashraf Kortam, PhDfirstname.lastname@example.org|
|Contact: Emad Khalefa, PhDemail@example.com|
|Contact: Emad Khalefa, PhD|
|Ain Shams University||Completed|
|Principal Investigator:||Ashraf Kortam, PhD||Ain Shams University|