Infertility, FemaleNCT03999541
Freeze-all Policy in Poor Responders
A study testing Freeze-all policy in people with Infertility, Female, run by Al-Yasmeen Fertility and Gynecology Center at 1 site in Egypt.
Trial summary
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Freeze-all policy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2019to 30 Dec 2020
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
- if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
- body mass index 18-32 kg/m2
- Both partners are able to provide written informed consent.
- At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
- Endometrial thickness ≥8 mm on trigger day.
- a normal uterine cavity on ultrasound.
- IVF/ICSI with only fresh semen
Who cannot join
- Pre-implantation genetic testing is being planned.
- if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Yasmeen Fertility and Gynecology Center
Banhā
Yasmin Magdi, Ph.D, 00201282313979, Yas.magdi@hotmail.com
About this study
Official title: Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.
- Conditions
- Infertility, Female
- Being tested
- Freeze-all policy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-all policyOther
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Freeze-all | Experimental | Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival. Receives: Other: Freeze-all policy |
| Fresh embryo transfer | No intervention | Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Livebirth rate
The proportion of women in the population who had at least one live baby.
Measured: 32 weeks
Secondary outcomes (2)
Pregnancy rate
Positive pregnancy test at two weeks +/- three days after embryo transfer
Measured: 2 weeks
Clinical pregnancy rate
The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start30 Jul 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Yasmeen Fertility and Gynecology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Magdi, Al-Yasmeen Fertility and Gynecology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999541
- Sponsor's protocol ID
- #0014
- Status last verified
- Jan 2020
- First submitted
- 22 Jun 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
- ClinicalTrials.gov ID
- NCT03999541
- Acronym / sponsor ID
- #0014
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Al-Yasmeen Fertility and Gynecology CenterUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Jun 2019 (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.
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-all | Experimental | Other: Freeze-all policyGood quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival. |
| Fresh embryo transfer | No intervention | –Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
- if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
- body mass index 18-32 kg/m2
- Both partners are able to provide written informed consent.
- At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
Key exclusion criteria (2 listed)
- Pre-implantation genetic testing is being planned.
- if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
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 |
|---|---|---|
| Freeze-all policyA policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer | Other | Freeze-all |
Primary outcome
Livebirth rate
Time frame: 32 weeks
The proportion of women in the population who had at least one live baby.
2 secondary outcomes
Pregnancy rate
Time frame: 2 weeks
Clinical pregnancy rate
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-all policy in people with Infertility, Female, run by Al-Yasmeen Fertility and Gynecology Center 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 8 inclusion and 2 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 28 Jan 2020. 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.
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 Yasmin Magdi, PhD (00201282313979, Yas.magdi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Livebirth rate (time frame: 32 weeks). 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 28 Jan 2020.