ICSIPhase 3NCT03788681
Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
A Phase 3 study testing Estradiol Valerate in people with ICSI, run by Ain Shams University at 1 site in Egypt.
Trial summary
The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . Read more about this study
- Who is it for?
- Ages 35 to 44 years, women only
- Conditions the study is for
- ICSI
- What is being tested?
- Estradiol Valerate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Sep 2019
- 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 35 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants included in this study will have the following criteria : ( 2 of 3 criteria )
- advanced maternal age or any other risk factor for POR :
- Age ≥35 years
- other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
- previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
- Abnormal ovarian reserve tests :
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- FSH ≥12 mIu/ml in the early follicular phase .
- Estradiol level more than 70 pg/dl in the early follicular phase
- Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
- Antral follicle count (AFC) < 5-7 follicles .
Who cannot join
- Age >35 with good ovarian response .
- any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
- Severe male factor infertility.
- Extended endometriosis (stage 3 or more) .
- All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, Abbassya, 11566
Mostafa f Gomaa, MD
About this study
The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.
- Conditions
- ICSI
- Being tested
- Estradiol Valerate, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol ValerateDrug
oral estradiol " estradiol valerate " (Cyclo-Progynova)
Placebo Oral TabletDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| oral estradiol " estradiol valerate | Active comparator | this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol " estradiol valerate " (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle. Receives: Drug: Estradiol Valerate |
| placebo | Placebo comparator | this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
the number of deliveries that resulted in a live born neonate
Measured: at least 28 weeks after ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start1 Apr 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICSIStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788681
- Sponsor's protocol ID
- Ain Shams Univ
- Status last verified
- Dec 2018
- First submitted
- 26 Dec 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT03788681
- Acronym / sponsor ID
- Ain Shams Univ
- Conditions
- ICSI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 27 Dec 2018 (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 role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral estradiol " estradiol valerate | Active comparator | Drug: Estradiol Valeratethis group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol " estradiol valerate " (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle. |
| placebo | Placebo comparator | Drug: Placebo Oral Tabletthis group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants included in this study will have the following criteria : ( 2 of 3 criteria )
Key exclusion criteria (5 listed)
- Age >35 with good ovarian response .
- any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
- Severe male factor infertility.
- Extended endometriosis (stage 3 or more) .
- All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer
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 Valerateoral estradiol " estradiol valerate " (Cyclo-Progynova) | Drug | oral estradiol " estradiol valerate |
| Placebo Oral Tabletplacebo | Drug | placebo |
Primary outcome
live birth rate
Time frame: at least 28 weeks after ET
the number of deliveries that resulted in a live born neonate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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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 Phase 3 study testing Estradiol Valerate in people with ICSI, run by Ain Shams 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 10 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 27 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa R Ali, MD (01283492979 ext. 02002, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: at least 28 weeks after ET). 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 27 Dec 2018.