Infertility, FemalePhase 3NCT04356105
Protocols of IVF/ICSI in Poor Responders
A Phase 3 study testing Minimal stimulation protocol, Microflare protocol and IVF/ICSI cycle in people with Infertility, Female, run by Cairo University at 2 sites in Egypt.
Trial summary
Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles Read more about this study
- Who is it for?
- Ages 30 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Minimal stimulation protocol, Microflare protocol and IVF/ICSI cycle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2020to 31 Oct 2021
- Phase
- Phase 3
- 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 30 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:
- Advanced maternal age
- Previous poor ovarian response
- Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)
Who cannot join
- Age > 43 years
- baseline FSH >15 mIU/ml
- Previous ovarian surgery
- Ovarian endometrioma
- Uterine anomaly or myoma
- Any medical disorder
Show all 9Show fewer
- Any hormonal disorder eg. hyperprolactinemia
- BMI > 30 kg/m2
- Severe male factor
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo, 12311
Cairo University
Cairo
About this study
Official title: Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study
Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
Read the detailed description
The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.
- Conditions
- Infertility, Female
- Being tested
- Minimal stimulation protocol, Microflare protocol, IVF/ICSI cycle
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal stimulation protocolDrug
Also called Ovarian induction protocol
Letrozole, Recombinant FSH, GnRH antagonist
Microflare protocolDrug
Also called Ovarian induction protocol
OCP, GnRH agonist, Recombinant FSH
IVF/ICSI cycleProcedure or surgery
Involving ovum pickup and embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Minimal Stimulation Group | Active comparator | Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist Receives: Drug: Minimal stimulation protocol; Procedure: IVF/ICSI cycle |
| Microflare Group | Active comparator | Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH Receives: Drug: Microflare protocol; Procedure: IVF/ICSI cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
the number of oocytes collected from each participants in the two groups on the day of ovum pickup
Measured: 10 to 14 days
Secondary outcomes (9)
Number of MII oocytes retrieved
The mature oocytes colloected on the day of ovum pickup
Measured: 10 to 14 days
Number of fertilized oocytes
Number of oocytes fertilized
Measured: 2 days
Number of embryos transferred
Number of embryos transferred in the induction cycle
Measured: Day 3 after ovum pickup
Number of embryos cryopreserved
Any surplus good quality embryos available for cryopreservation
Measured: Day 3 after ovum pickup
Chemical pregnancy rate
Positive pregnancy test
Measured: 14 days after embryo ransfer
Clinical pregnancy rate
Positive heart beat
Measured: 5 to 7 weeks after embryo transfer
Early miscarriage rate
loss of pregnancy before 12 weeks
Measured: 12 weeks
Ongoing pregnancy rate
pregnancy beyond 12 weeks
Measured: 12 weeks
Live birth rate
Delivery beyond 28 weeks
Measured: 28 to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ahmed Bassiouny, Cairo University
- Investigators
- Sarwat Ahwany, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356105
- Sponsor's protocol ID
- 12020
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study
- ClinicalTrials.gov ID
- NCT04356105
- Acronym / sponsor ID
- 12020
- Conditions
- Infertility, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 22 Apr 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.
Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
Detailed description
The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
| Arm | Type | Receives |
|---|---|---|
| Minimal Stimulation Group | Active comparator | Drug: Minimal stimulation protocol, Procedure: IVF/ICSI cycleMinimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist |
| Microflare Group | Active comparator | Drug: Microflare protocol, Procedure: IVF/ICSI cycleMicroflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH |
Who may qualify
- Ages
- 30 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:
- Advanced maternal age
- Previous poor ovarian response
- Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)
Key exclusion criteria (9 listed)
- Age > 43 years
- baseline FSH >15 mIU/ml
- Previous ovarian surgery
- Ovarian endometrioma
- Uterine anomaly or myoma
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 |
|---|---|---|
| Minimal stimulation protocolAlso: Ovarian induction protocolLetrozole, Recombinant FSH, GnRH antagonist | Drug | Minimal Stimulation Group |
| Microflare protocolAlso: Ovarian induction protocolOCP, GnRH agonist, Recombinant FSH | Drug | Microflare Group |
| IVF/ICSI cycleInvolving ovum pickup and embryo transfer | Procedure or surgery | Microflare Group, Minimal Stimulation Group |
Primary outcome
Number of oocytes retrieved
Time frame: 10 to 14 days
the number of oocytes collected from each participants in the two groups on the day of ovum pickup
9 secondary outcomes
Number of MII oocytes retrieved
Time frame: 10 to 14 days
Number of fertilized oocytes
Time frame: 2 days
Number of embryos transferred
Time frame: Day 3 after ovum pickup
Number of embryos cryopreserved
Time frame: Day 3 after ovum pickup
Chemical pregnancy rate
Time frame: 14 days after embryo ransfer
Clinical pregnancy rate
Time frame: 5 to 7 weeks after embryo transfer
Early miscarriage rate
Time frame: 12 weeks
Ongoing pregnancy rate
Time frame: 12 weeks
Live birth rate
Time frame: 28 to 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
Sarwat Ahwany, MD study director
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 3 study testing Minimal stimulation protocol, Microflare protocol and IVF/ICSI cycle in people with Infertility, Female, run by Cairo University 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 4 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: finished, as of the sponsor's last update on 16 Nov 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved (time frame: 10 to 14 days). 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 16 Nov 2021.