InfertilityPhase 4NCT02330757
HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
A Phase 4 study testing Estradiol valerate and Sequential Clomiphene citrate and Gonadotropin in people with Infertility, run by Mansoura University at 2 sites in Egypt.
Trial summary
Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS) Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Estradiol valerate and Sequential Clomiphene citrate and Gonadotropin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Oct 2016to 31 Dec 2024
- Phase
- Phase 4
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women without PCOS as defined by the Rotterdam criteria.
- Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).
Who cannot join
- PCOS or polycystic ovary on ultrasound scan.
- Moderate or severe endometriosis.
- Hydrosalpinx.
- Uterine abnormalities or myoma.
- Previous uterine surgery.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Mohamed S Abdelhafez, Dr, +201144523366, msabdelhafez@gmail.com
- Recruiting
Private fertility care centers
Al Mansurah, Dakahlia Governorate
About this study
Official title: Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients
Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)
Read the detailed description
Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.
- Conditions
- Infertility
- Being tested
- Estradiol valerate, Sequential Clomiphene citrate and Gonadotropin
- Keywords
- Frozen-thawed embryo transfer, FET protocols
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerateDrug
Also called Cycloprogynova (white tablets)
Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
Sequential Clomiphene citrate and GonadotropinDrug
Also called Sequential Clomid and Menogon
Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| HRT group | Active comparator | Women will be subjected to HRT using Estradiol valerate before FET Receives: Drug: Estradiol valerate |
| MOS group | Active comparator | Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET Receives: Drug: Sequential Clomiphene citrate and Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Measured: 6 weeks after embryo transfer
Secondary outcomes (2)
Implantation rate
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Measured: 6 weeks after embryo transfer
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Measured: 12 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study start10 Oct 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Mohamed S Abdelhafez, Dr, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330757
- Sponsor's protocol ID
- MSA2
- Status last verified
- Oct 2023
- First submitted
- 1 Jan 2015
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients
- ClinicalTrials.gov ID
- NCT02330757
- Acronym / sponsor ID
- MSA2
- Conditions
- Infertility
- Keywords
- Frozen-thawed embryo transfer, FET protocols
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jan 2015 (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.
Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)
Detailed description
Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRT group | Active comparator | Drug: Estradiol valerateWomen will be subjected to HRT using Estradiol valerate before FET |
| MOS group | Active comparator | Drug: Sequential Clomiphene citrate and GonadotropinWomen will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women without PCOS as defined by the Rotterdam criteria.
- Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).
Key exclusion criteria (5 listed)
- PCOS or polycystic ovary on ultrasound scan.
- Moderate or severe endometriosis.
- Hydrosalpinx.
- Uterine abnormalities or myoma.
- Previous uterine surgery.
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 |
|---|---|---|
| Estradiol valerateAlso: Cycloprogynova (white tablets)Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. | Drug | HRT group |
| Sequential Clomiphene citrate and GonadotropinAlso: Sequential Clomid and MenogonWomen will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. | Drug | MOS group |
Primary outcome
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
2 secondary outcomes
Implantation rate
Time frame: 6 weeks after embryo transfer
Miscarriage rate
Time frame: 12 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- 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.
Mohamed S Abdelhafez, Dr principal investigator
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol valerate and Sequential Clomiphene citrate and Gonadotropin in people with Infertility, run by Mansoura 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 2 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 30 Oct 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed S Abdelhafez, Dr (+201144523366, msabdelhafez@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: 6 weeks 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 30 Oct 2023.