InfertilityPhase 3NCT02736032
Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
A Phase 3 study testing Embryo transfer, Serum Estradiol and Progesterone levels and GnRH agonist in people with Infertility, run by Cairo University at 3 sites in Egypt.
Trial summary
Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer, Serum Estradiol and Progesterone levels and GnRH agonist
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 3 sitesEgypt
- Study dates
- Mar 2016to May 2018
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20-35 years
- BMI 20-30
- Regular menses.
- No PCOS, no endometriosis
- No uterine anomalies or lesions
- No severe male factor
- All grade 1 cleaved stage embryos
Who cannot join
- Less than 20 or more than 35 years
- BMI less than 20 or more than 30
- Irregular cycles
- PCOS or endometriosis
- Uterine anomalies or lesions
- Severe male factor
- Poor quality embryos for transfer
- Severe
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo, 12411
Kamal Shaeer center of infertility
Giza, 12411
Nile IVF center
Giza, 12411
About this study
Official title: Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study
Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.
- Conditions
- Infertility
- Being tested
- Embryo transfer, Serum Estradiol and Progesterone levels, GnRH agonist, External Estradiol, Progesterone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transferProcedure or surgery
The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
Serum Estradiol and Progesterone levelsProcedure or surgery
Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation
GnRH agonistDrug
Also called Decapeptyl SR
GnRH agonist given on day 21 of the cycle preceding the embryo transfer
External EstradiolDrug
Also called estradiol valerate of Cycloprogenova tablets
Estradiol started on day1 of the cycle for endometrial prepartaion
ProgesteroneDrug
Also called Cyclogest vaginal suppositories
progesterone as luteal phase support start after endometrium is well prepared
| Study group | Role | What they receive |
|---|---|---|
| With GnRHa | Active comparator | Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Receives: Procedure: Embryo transfer; Procedure: Serum Estradiol and Progesterone levels; Drug: GnRH agonist; Drug: External Estradiol; Drug: Progesterone |
| Without GnRHa | Active comparator | Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Receives: Procedure: Embryo transfer; Procedure: Serum Estradiol and Progesterone levels; Drug: External Estradiol; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
the detection of intrauterine gestational sac with positive pulsations
Measured: 5 weeks after embryo transfer]
Live birth rate
Pregnancy ending with a live birth
Measured: 9 months
Secondary outcomes (8)
Estradiol and Progesterone levels on day of start of progesterone supplementation
The serum levels of estradiol and progesterone before embryo transfer
Measured: 12 to 20 days
Endometrial thickness on day of start of progesterone supplementation
The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos
Measured: 12 to 20 days
Number of days needed for adequate (> 8mm) endometrial thickness
Number of days on external hormones to prepare endometrium
Measured: 12 to 20 days
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.
Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.
Measured: 12 to 20 days
Chemical pregnancy rate
positive serum Beta HCG 14 days after embryo transfer
Measured: 14 days after embryo transfer
Implantation rate.
the ratio between the number of embryos transferred and the number of sacs
Measured: 5 weeks after embryo transfer
Early miscarriage rate
Pregnancy loss in the first 12 weeks gestation
Measured: 3 months
Ongoing pregnancy rate
Pregnancy ongoing beyond 12 weeks gestation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility
- Responsible party
- Principal investigator, Yasmin Ahmed Bassiouny, Cairo University
- Investigators
- Eman K Shaeer, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736032
- Sponsor's protocol ID
- 12016
- Status last verified
- May 2018
- First submitted
- 30 Mar 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02736032
- Acronym / sponsor ID
- 12016
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Apr 2016 (estimated)
- 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.
Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With GnRHa | Active comparator | Procedure: Embryo transfer, Procedure: Serum Estradiol and Progesterone levels, Drug: GnRH agonist, Drug: External Estradiol, Drug: ProgesteroneCryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. |
| Without GnRHa | Active comparator | Procedure: Embryo transfer, Procedure: Serum Estradiol and Progesterone levels, Drug: External Estradiol, Drug: ProgesteroneCryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20-35 years
- BMI 20-30
- Regular menses.
- No PCOS, no endometriosis
- No uterine anomalies or lesions
Key exclusion criteria (8 listed)
- Less than 20 or more than 35 years
- BMI less than 20 or more than 30
- Irregular cycles
- PCOS or endometriosis
- Uterine anomalies or lesions
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 |
|---|---|---|
| Embryo transferThe transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy | Procedure or surgery | With GnRHa, Without GnRHa |
| Serum Estradiol and Progesterone levelsSerum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation | Procedure or surgery | With GnRHa, Without GnRHa |
| GnRH agonistAlso: Decapeptyl SRGnRH agonist given on day 21 of the cycle preceding the embryo transfer | Drug | With GnRHa |
| External EstradiolAlso: estradiol valerate of Cycloprogenova tabletsEstradiol started on day1 of the cycle for endometrial prepartaion | Drug | With GnRHa, Without GnRHa |
| ProgesteroneAlso: Cyclogest vaginal suppositoriesprogesterone as luteal phase support start after endometrium is well prepared | Drug | With GnRHa, Without GnRHa |
Primary outcome
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer]
the detection of intrauterine gestational sac with positive pulsations
Live birth rate
Time frame: 9 months
Pregnancy ending with a live birth
8 secondary outcomes
Estradiol and Progesterone levels on day of start of progesterone supplementation
Time frame: 12 to 20 days
Endometrial thickness on day of start of progesterone supplementation
Time frame: 12 to 20 days
Number of days needed for adequate (> 8mm) endometrial thickness
Time frame: 12 to 20 days
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.
Time frame: 12 to 20 days
Chemical pregnancy rate
Time frame: 14 days after embryo transfer
Implantation rate.
Time frame: 5 weeks after embryo transfer
Early miscarriage rate
Time frame: 3 months
Ongoing pregnancy rate
Time frame: 3 months
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 17 May 2018.
- 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.
Eman K Shaeer, MD study director
Cairo University
3 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 Embryo transfer, Serum Estradiol and Progesterone levels and GnRH agonist in people with Infertility, run by Cairo University at 3 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 7 inclusion and 8 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Clinical pregnancy rate (time frame: 5 weeks after embryo transfer]). The study lists 2 primary outcomes in all. 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 17 May 2018.