IVFNCT05167838
Comparative Study Between Fresh and Frozen Embryo Transfer in PCOS Patients Undergoing IVF Treatment
A study testing fresh embryo transfer and Frozen embryo transfer in people with IVF, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- fresh embryo transfer and Frozen embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 2022
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries.
- Women ages ≥20 and <40years old.
- BMI less than 35.
- Women who have a history of infertility.
- All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up).
Who cannot join
- History of unilateral oophorectomy.
- Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion.
- Severe male factor for infertility such as azoospermia.
- History of repeated ICSI trials failure.
- Women who are unable to comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Marwa Eid
Cairo
Marwa M Eid, MD, 01001225079, marwameid2014@gmail.com
Abdullah S Ha, Ass.lecturer, 01001409468, elbehiry32@gmail.com
About this study
Official title: A Comparative Study Between Fresh and Frozen Embryo Transfer in Cases of Polycystic Ovaries Syndrome (PCOS) Patients Undergoing in Vitro Fertilization (IVF) Treatment for Infertility as Regards Clinical Pregnancy Rate and IVF Outcome
The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).
Read the detailed description
Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups:
Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer.
Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.
- Conditions
- IVF
- Being tested
- fresh embryo transfer, Frozen embryo transfer
- Keywords
- IVF-Fresh ET-FET-clinical pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh embryo transferProcedure or surgery
55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support
Frozen embryo transferProcedure or surgery
55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Fresh embryo transfer group Receives: Procedure: fresh embryo transfer |
| Group B | Experimental | Frozen embryo transfer group Receives: Procedure: Frozen embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Transvaginal Ultrasound to detect gestational sac(GS)
Measured: 35 days after embryo transfer
Secondary outcomes (3)
Chemical pregnancy rate
Serum β-human chorionic gonadotropin (HCG) will be measured to determine pregnancy after embryo transfer.
Measured: 14 days after embryo transfer.
Early ovarian hyperstimulation syndrome rate(OHSS rate)
Abdominal ultrasound ,Hematocrit
Measured: 3 days after follicular aspiration
Ectopic pregnancy rate
BHCG then doubling after 48 hours ,vaginal ultrasound
Measured: 14 days for BHCG , vaginal US 3 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Mahmoud Eid, Cairo University
- Investigators
- Marwa Mo Eid, MD, Principal investigator, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167838
- Sponsor's protocol ID
- Cairo University obgyn
- Status last verified
- Apr 2022
- First submitted
- 23 Nov 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Fresh and Frozen Embryo Transfer in Cases of Polycystic Ovaries Syndrome (PCOS) Patients Undergoing in Vitro Fertilization (IVF) Treatment for Infertility as Regards Clinical Pregnancy Rate and IVF Outcome
- ClinicalTrials.gov ID
- NCT05167838
- Acronym / sponsor ID
- Cairo University obgyn
- Conditions
- IVF
- Keywords
- IVF-Fresh ET-FET-clinical pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 22 Dec 2021 (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 objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).
Detailed description
Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups:
Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer.
Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: fresh embryo transferFresh embryo transfer group |
| Group B | Experimental | Procedure: Frozen embryo transferFrozen embryo transfer group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries.
- Women ages ≥20 and <40years old.
- BMI less than 35.
- Women who have a history of infertility.
- All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up).
Key exclusion criteria (5 listed)
- History of unilateral oophorectomy.
- Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion.
- Severe male factor for infertility such as azoospermia.
- History of repeated ICSI trials failure.
- Women who are unable to comply with the study procedures.
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 |
|---|---|---|
| fresh embryo transfer55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support | Procedure or surgery | group A |
| Frozen embryo transfer55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle. | Procedure or surgery | Group B |
Primary outcome
Clinical pregnancy rate
Time frame: 35 days after embryo transfer
Transvaginal Ultrasound to detect gestational sac(GS)
3 secondary outcomes
Chemical pregnancy rate
Time frame: 14 days after embryo transfer.
Early ovarian hyperstimulation syndrome rate(OHSS rate)
Time frame: 3 days after follicular aspiration
Ectopic pregnancy rate
Time frame: 14 days for BHCG , vaginal US 3 weeks after transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marwa Mo Eid, MD principal investigator
Cairo U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fresh embryo transfer and Frozen embryo transfer in people with IVF, run by Cairo University 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 5 inclusion and 5 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 12 Apr 2022. 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 Marwa Mo Eid, Ass.prof (01001225079, marwameid2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 35 days after embryo transfer). 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 12 Apr 2022.