InfertilityPhase 2NCT07569315
Successive Doses of GnRH Agonist Versus Single Dose of GnRH Agonist to Trigger Ovulation in Hyper-responders
A Phase 2 study testing Successive doses GnRH agonist and Single dose GnRH agonist in people with Infertility, run by Bedaya Hospital at 1 site in Egypt.
Trial summary
The aim of this randomized controlled study is to compare the efficacy of three successive doses of a GnRH agonist ( administered 36 , 24 and 12 hours before oocyte retrieval ) with a single dose of a GnRH agonist ( administered 36 hours before oocyte retrieval ) in triggering ovulation in hyper-responders Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Successive doses GnRH agonist and Single dose GnRH agonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GnRH antagonist IVF cycle
- Hyper-responders to induction of ovulation
Who cannot join
- Hypogonadotrophic hypogonadism
- Endometriosis
- History of recurrent abortion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Bedaya Hospital
Giza
Usama M. Fouda, Prof, umfrfouda@yahoo.com
Ahmed Gadallah
About this study
Official title: Successive Doses of GnRH Agonist Versus Single Dose of GnRH Agonist to Trigger Ovulation in Hyper-responders Undergoing IVF Cycle : A Randomized Controlled Study.
The aim of this randomized controlled study is to compare the efficacy of three successive doses of a GnRH agonist ( administered 36 , 24 and 12 hours before oocyte retrieval ) with a single dose of a GnRH agonist ( administered 36 hours before oocyte retrieval ) in triggering ovulation in hyper-responders
- Conditions
- Infertility
- Being tested
- Successive doses GnRH agonist, Single dose GnRH agonist
- Keywords
- Infertility, GnRH agonist trigger, IVF-ET, Hyper-responders, PCOS
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successive doses GnRH agonistDrug
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup. Two additional doses of triptorelin ( 0.1 mg / S.C ) are administered subcutaneously 12 and 24 hours after the first dose of GnRH agonist.
Single dose GnRH agonistDrug
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup.
| Study group | Role | What they receive |
|---|---|---|
| Successive doses GnRH agonist | Experimental | Three successive doses of GnRH agonist are administered 36 , 24 and 12 hours before oocyte retrieval Receives: Drug: Successive doses GnRH agonist |
| Single dose GnRH agonist | Active comparator | A single dose of GnRH agonist is administered 36 hours before oocyte retrieval Receives: Drug: Single dose GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase-II oocytes rate
Number of MII oocyte/ number of cumulus oocyte complex
Measured: Ten to fifteen days after starting ovarian stimulation
Secondary outcomes (2)
Clinical pregnancy rate
Presence of intrauterine gestational sac detected by transvaginal ultrasound
Measured: Five weeks after embryo transfer
Ongoing pregnancy Rate
Pregnancies continued beyond 20 weeks gestation
Measured: Eighteen weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569315
- Sponsor's protocol ID
- Successive/Single GnRH agonist
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hashemi SH, Hafezi M, Arabipoor A, Zareei M, Vesali S, Eftekhari-Yazdi P. Can We Harvest More Mature Oocytes by Repeating Gonadotropin-Releasing Hormone Agonist Doses in Polycystic Ovarian Syndrome Patients at Risk of OHSS in Antagonist Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):48-54. doi: 10.22074/ijfs.2023.2008905.1513.
PubMed 39033370
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successive Doses of GnRH Agonist Versus Single Dose of GnRH Agonist to Trigger Ovulation in Hyper-responders Undergoing IVF Cycle : A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07569315
- Acronym / sponsor ID
- Successive/Single GnRH agonist
- Conditions
- Infertility
- Keywords
- Infertility, GnRH agonist trigger, IVF-ET, Hyper-responders, PCOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Bedaya HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 6 May 2026 (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 randomized controlled study is to compare the efficacy of three successive doses of a GnRH agonist ( administered 36 , 24 and 12 hours before oocyte retrieval ) with a single dose of a GnRH agonist ( administered 36 hours before oocyte retrieval ) in triggering ovulation in hyper-responders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successive doses GnRH agonist | Experimental | Drug: Successive doses GnRH agonistThree successive doses of GnRH agonist are administered 36 , 24 and 12 hours before oocyte retrieval |
| Single dose GnRH agonist | Active comparator | Drug: Single dose GnRH agonistA single dose of GnRH agonist is administered 36 hours before oocyte retrieval |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- GnRH antagonist IVF cycle
- Hyper-responders to induction of ovulation
Key exclusion criteria (3 listed)
- Hypogonadotrophic hypogonadism
- Endometriosis
- History of recurrent abortion
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 |
|---|---|---|
| Successive doses GnRH agonistGnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup. Two additional doses of triptorelin ( 0.1 mg / S.C ) are administered subcutaneously 12 and 24 hours after the first dose of GnRH agonist. | Drug | Successive doses GnRH agonist |
| Single dose GnRH agonistGnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup. | Drug | Single dose GnRH agonist |
Primary outcome
Metaphase-II oocytes rate
Time frame: Ten to fifteen days after starting ovarian stimulation
Number of MII oocyte/ number of cumulus oocyte complex
2 secondary outcomes
Clinical pregnancy rate
Time frame: Five weeks after embryo transfer
Ongoing pregnancy Rate
Time frame: Eighteen weeks after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 39033370Hashemi SH, Hafezi M, Arabipoor A, Zareei M, Vesali S, Eftekhari-Yazdi P. Can We Harvest More Mature Oocytes by Repeating Gonadotropin-Releasing Hormone Agonist Doses in Polycystic Ovarian Syndrome Patients at Risk of OHSS in Antagonist Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):48-54. doi: 10.22074/ijfs.2023.2008905.1513.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Successive doses GnRH agonist and Single dose GnRH agonist in people with Infertility, run by Bedaya Hospital at 1 site 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 3 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Usama M. Fouda, Prof. (+201095401375, umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metaphase-II oocytes rate (time frame: Ten to fifteen days after starting ovarian stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07569315, which also lists 1 linked publication.
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 11 May 2026.