InfertilityPhase 2NCT06212102
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation
A Phase 2 study testing Progestin primed ovarian stimulation and GnRH antagonist in people with Infertility, run by Bedaya Hospital at 2 sites in Egypt.
Trial summary
The aim of this randomized controlled trial is to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol. Read more about this study
- Who is it for?
- Ages 35 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Progestin primed ovarian stimulation and GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 8 May 2024to 1 Aug 2027
- 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 35 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients belonging to Poseidon group 4
Who cannot join
- PCOS
- Endometriosis
- History of recurrent abortion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate
Usama M Fouda, Prof, +201095401375, umfrfouda@yahoo.com
Samar A Alhofy, M.D, Msc
- Not yet recruiting
Bedaya Hospital
Giza
Usama M. Fouda, Prof, umfrfouda@yahoo.com
Samar A Alhofy, M.D, Msc
About this study
Official title: Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial
The aim of this randomized controlled trial is to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.
- Conditions
- Infertility
- Being tested
- Progestin primed ovarian stimulation, GnRH antagonist
- Keywords
- Infertility, IVF-ET, Poor ovarian responders, Double stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progestin primed ovarian stimulationDrug
HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.
GnRH antagonistDrug
HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.
| Study group | Role | What they receive |
|---|---|---|
| Progestin primed ovarian stimulation group | Experimental | HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.
In subsequent cycle, frozen embryo transfer was done Receives: Drug: Progestin primed ovarian stimulation |
| GnRH antagonist group | Active comparator | HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.
In subsequent cycle, frozen embryo transfer was done Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medications costs per retrieved oocyte
Total cost of medications used in all cycles/number of retrieved oocytes
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: 5 weeks after embryo transfer]
Ongoing Pregnancy Rate
Pregnancies continued beyond 20 weeks gestation
Measured: 18 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 posted18 Jan 2024
- Study start8 May 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Aug 2027 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedaya Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Samar A Alhofy, M.D, Msc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212102
- Sponsor's protocol ID
- Double stimulation
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.
PubMed 27020168
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06212102
- Acronym / sponsor ID
- Double stimulation
- Conditions
- Infertility
- Keywords
- Infertility, IVF-ET, Poor ovarian responders, Double stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bedaya HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Jan 2024 (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 trial is to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progestin primed ovarian stimulation group | Experimental | Drug: Progestin primed ovarian stimulationHMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS. In subsequent cycle, frozen embryo transfer was done |
| GnRH antagonist group | Active comparator | Drug: GnRH antagonistHMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS. In subsequent cycle, frozen embryo transfer was done |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients belonging to Poseidon group 4
Key exclusion criteria (3 listed)
- PCOS
- 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 |
|---|---|---|
| Progestin primed ovarian stimulationHMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS. | Drug | Progestin primed ovarian stimulation group |
| GnRH antagonistHMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS. | Drug | GnRH antagonist group |
Primary outcome
Medications costs per retrieved oocyte
Time frame: Ten to fifteen days after starting ovarian stimulation]
Total cost of medications used in all cycles/number of retrieved oocytes
2 secondary outcomes
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer]
Ongoing Pregnancy Rate
Time frame: 18 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 4 May 2026.
- Background: PubMed 27020168Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.
- 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.
Samar A Alhofy, M.D, Msc principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progestin primed ovarian stimulation and GnRH antagonist in people with Infertility, run by Bedaya Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 4 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 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 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?
Medications costs per retrieved oocyte (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 NCT06212102, 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 4 May 2026.