Female InfertilityPhase 4GIVFNCT03057574
Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
A Phase 4 study testing Follitropin Alfa in people with Female Infertility, run by MinaPharm Pharmaceuticals at 2 sites in Egypt.
Trial summary
This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for female subjects with infertility Undergoing IVF/ICSI Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Follitropin Alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 9 Feb 2017to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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have given written informed consent, prior to any trial-related procedure, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.
Who cannot join
- 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 ®.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Emad Khalefa, PhD contact
Egypt2 sites, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Emad Khalefa, PhD
- Completed
Ain Shams University
Cairo
About this study
Official title: 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
Read the 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.
- Conditions
- Female Infertility
- Being tested
- Follitropin Alfa
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin AlfaDrug
Also called Gonapure ®
Patients must be prescribed Follitropin Alfa (Gonapure®)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Follitropin Alfa (Gonapure) Receives: Drug: Follitropin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved on the day of Ovum Pick-Up
Measured: 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.
Measured: 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.
Measured: 50 days after baseline visit (EOS)
Secondary outcomes (5)
Eventual AE/SAEs related to the administration of Gonapure®
Measured: 50 days after baseline visit (EOS)
Total & Mean Gonapure ® Daily Dose
Time Frame: Start of treatment until end of stimulation cycle
Measured: 14 days
Number of follicles ≥ 18 mm on day of administration of hCG
Measured: 50 days after baseline visit (EOS)
Number of Participants with Multiple Pregnancies
Multiple pregnancies were defined as 2 or more fetal hearts with activity.
Measured: 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.
Measured: 50 days after baseline visit (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start9 Feb 2017
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashraf Kortam, PhD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057574
- Sponsor's protocol ID
- r-hFSH13082013
- Acronym
- GIVF
- Status last verified
- Aug 2017
- First submitted
- 30 Nov 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
- ClinicalTrials.gov ID
- NCT03057574
- Acronym / sponsor ID
- GIVF / r-hFSH13082013
- Conditions
- Female Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Follitropin AlfaFollitropin Alfa (Gonapure) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin AlfaAlso: Gonapure ®Patients must be prescribed Follitropin Alfa (Gonapure®) | Drug | Treatment |
Primary outcome
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: * 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.
5 secondary outcomes
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
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)
Number of Participants with Ovarian Hyperstimulation Syndrome
Time frame: 50 days after baseline visit (EOS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Khalefa, PhD contact
Ashraf Kortam, PhD principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Follitropin Alfa in people with Female Infertility, run by MinaPharm Pharmaceuticals at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Kortam, PhD (+201001433714, oeissa@minapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved on the day of Ovum Pick-Up (time frame: 50 days after baseline visit (EOS)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.