IVFPhase 4NCT04385342
FSH Followed by HMG vs FSH Plus HMG in IVF
A Phase 4 study testing FSH and HP-hMG in people with IVF, run by Mansoura University at 3 sites in Egypt.
Trial summary
The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- FSH and HP-hMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 3 sitesEgypt
- Study dates
- 30 Jun 2020to 31 Aug 2022
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol.
- Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).
Who cannot join
- Age < 20 or > 37 years.
- Body mass index (BMI) < 18 or > 30 kg/m2.
- Low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml).
- Presence of polycystic ovarian syndrome (PCOS).
- Endometrioma or hydrosalpinx.
- History of chemotherapy, radiotherapy or ovarian surgery.
- The husband needs testicular biopsy to obtain sperm.
- Previous implantation failure.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Not yet recruiting
Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Hamed Yossef, MD
- Recruiting
Department of Obstetrics and Gynecology
Alexandria
Hasan El Maghraby, MD
- Not yet recruiting
RAHEM Fertility Centre
Zagazig
Eman Elgindy, PhD, eman_elgindy2013@hotmail.com
About this study
Official title: Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization
The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.
Read the detailed description
Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol will be assessed for possibility of participation in our study. Eligible participants in our study will be those with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).
Women with any of the following criteria will be excluded from the study: 1) age < 20 or > 37 years; 2) body mass index (BMI) < 18 or > 25 kg/m2; 3) low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml); 4) presence of polycystic ovarian syndrome (PCOS), endometrioma or hydrosalpinx; 5) history of chemotherapy, radiotherapy or ovarian surgery; 6) the husband needs testicular biopsy to obtain sperm; or 7) previous implantation failure.
A written informed consent will be taken from each women selected to participate before inclusion in the study. All women participating in the study will start GnRHa on day 21 of the preceding cycle and when down regulation occurs each woman will be randomly allocated into one of the two groups; group 1 and group 2. Women in group 1 will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering. Women in group 2 will receive 150 IU FSH plus 75 IU HP-hMG from day one of ovarian stimulation and 150IU HP-HMG when the follicular diameters reaches 10-12 mm till day of triggering. The randomization will be simple and balanced (1:1) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The data assesor will be blinded to group assignment.
In both groups, estradiol and LH will be measured on the third day of menstruation before start of stimulation and on day 6 of stimulation TVS will be performed. Progesterone and E2 will be measured and on day of triggering. The primary outcome measure of this study will be the ongoing pregnancy rate. The secondary outcomes measures will be cancellation rate, the number of oocytes retrieved, the number of embryos, the number of vitrified embryos, the clinical pregnancy rate, the implantation rate, OHSS rate, multiple pregnancy rate, and the miscarriage rate.
- Conditions
- IVF
- Being tested
- FSH, HP-hMG
- Keywords
- ovarian stimulation, subfertility, FSH, HMG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSHDrug
Also called Fostimon, Gonal-F, Puragon
Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG
HP-hMGDrug
Also called Meriofert, Menopure
Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG
| Study group | Role | What they receive |
|---|---|---|
| FSH then HP-hMG | Active comparator | Women will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering Receives: Drug: FSH; Drug: HP-hMG |
| FSH + HP-hMG | Active comparator | Women will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering Receives: Drug: FSH; Drug: HP-hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Number of ongoing pregnancies (defined as pregnancies passed beyond 12 weeks gestational age) divided by the number of women randomized
Measured: 12 weeks gestational age
Secondary outcomes (3)
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of women randomized
Measured: 6 weeks after embryo transfer
Implantation rate
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Measured: 6 weeks after embryo transfer
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Measured: 12 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Gibreel, MD, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, MD, Study director, Mansoura UniversityHasan El Maghraby, MD, Study director, Alexandria UniversityHamed Yossef, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385342
- Sponsor's protocol ID
- R.20.04.823
- Status last verified
- Jun 2020
- First submitted
- 10 Jan 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT04385342
- Acronym / sponsor ID
- R.20.04.823
- Conditions
- IVF
- Keywords
- ovarian stimulation, subfertility, FSH, HMG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 May 2020 (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.
The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.
Detailed description
Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol will be assessed for possibility of participation in our study. Eligible participants in our study will be those with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).
Women with any of the following criteria will be excluded from the study: 1) age < 20 or > 37 years; 2) body mass index (BMI) < 18 or > 25 kg/m2; 3) low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml); 4) presence of polycystic ovarian syndrome (PCOS), endometrioma or hydrosalpinx; 5) history of chemotherapy, radiotherapy or ovarian surgery; 6) the husband needs testicular biopsy to obtain sperm; or 7) previous implantation failure.
A written informed consent will be taken from each women selected to participate before inclusion in the study. All women participating in the study will start GnRHa on day 21 of the preceding cycle and when down regulation occurs each woman will be randomly allocated into one of the two groups; group 1 and group 2. Women in group 1 will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering. Women in group 2 will receive 150 IU FSH plus 75 IU HP-hMG from day one of ovarian stimulation and 150IU HP-HMG when the follicular diameters reaches 10-12 mm till day of triggering. The randomization will be simple and balanced (1:1) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The data assesor will be blinded to group assignment.
In both groups, estradiol and LH will be measured on the third day of menstruation before start of stimulation and on day 6 of stimulation TVS will be performed. Progesterone and E2 will be measured and on day of triggering. The primary outcome measure of this study will be the ongoing pregnancy rate. The secondary outcomes measures will be cancellation rate, the number of oocytes retrieved, the number of embryos, the number of vitrified embryos, the clinical pregnancy rate, the implantation rate, OHSS rate, multiple pregnancy rate, and the miscarriage rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSH then HP-hMG | Active comparator | Drug: FSH, Drug: HP-hMGWomen will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering |
| FSH + HP-hMG | Active comparator | Drug: FSH, Drug: HP-hMGWomen will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol.
- Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).
Key exclusion criteria (8 listed)
- Age < 20 or > 37 years.
- Body mass index (BMI) < 18 or > 30 kg/m2.
- Low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml).
- Presence of polycystic ovarian syndrome (PCOS).
- Endometrioma or hydrosalpinx.
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 |
|---|---|---|
| FSHAlso: Fostimon, Gonal-F, PuragonControlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG | Drug | FSH + HP-hMG, FSH then HP-hMG |
| HP-hMGAlso: Meriofert, MenopureControlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG | Drug | FSH + HP-hMG, FSH then HP-hMG |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks gestational age
Number of ongoing pregnancies (defined as pregnancies passed beyond 12 weeks gestational age) divided by the number of women randomized
3 secondary outcomes
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Implantation rate
Time frame: 6 weeks after embryo transfer
Miscarriage rate
Time frame: 12 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
Ahmed Gibreel, MD principal investigator
Mansoura University
Mohamed S Abdelhafez, MD study director
Mansoura University
Hasan El Maghraby, MD study director
Alexandria University
3 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 FSH and HP-hMG in people with IVF, run by Mansoura University at 3 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 2 inclusion and 8 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Ahmed Gibreel, MD (01221191133, ahmedfathgi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks gestational age). 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 9 Jun 2020.