Oestradiol Supplementation in Luteal Long Agonist Fresh In Vitro Fertilization/Intra Cytoplasmic Sperm Injection ( IVF/ICSI) Cycle .
NCT ID: NCT03832894
Last Updated: 2019-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
2 participants
INTERVENTIONAL
2018-12-01
2020-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
NCT03788681
The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
NCT03209687
Is Adding E2 to P4 Luteal Support In High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Outcome? RCT
NCT01790282
Effect of Estradiol Pretreatment on Antagonist ICSI Cycles
NCT05197374
Timing of Initiation of Luteal Phase Support in Poor Responders Undergoing IVF/ICSI
NCT03938064
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Compromised granulosa cells luteinisation could cause infertility or early miscarriage. In assisted reproductive technologies (ART) cycles, curettage of the granulosa cells during oocyte retrieval is thought to reduce corpora lutea function and thus progesterone production, resulting in a decrease in pregnancy rate.
Therefore, luteal support is routinely performed in ART cycles. Consensus has been reached on the supplementation of progesterone after the day of oocyte retrieval, which was performed in approximately 80% of the cycles and significantly improved clinical outcomes.However, the efficacy of oestradiol supplementation in luteal support remains controversial.
Previous studies have shown that the lower the serum estrogen level was at 4, 7 and 9 days following transplantation, the lower the clinical pregnancy rate. Previous studies showed that in patients with long or short duration ovulation induction, luteal support with oestradiol supplementation led to an increased serum estrogen level and an improved pregnancy rate . It was also found that patients having luteal support with estrogen (4 mg per day) had a significantly higher clinical pregnancy rate (40.6% vs 21.6%) and a significantly lower abortion rate (12.8% vs 38%) than those treated with progesterone alone.
In contrast, other investigators have failed to show any benefit of oestradiol supplementation during the luteal phase and a Cochrane review published in 2015 reported no differences in rates of live birth or ongoing pregnancy between the progesterone group and progesterone add oestrogen group. Hence, it remains unclear whether the addition of estrogen to progesterone for luteal support is associated with higher pregnancy rate and live birth rate.
In this study, the investigators will evaluate outcomes of patients undergoing IVF/ICSI-ET with oestradiol supplementation in addition to progesterone for luteal support. The investigators also report on the efficacy implications of oestradiol supplementation for patients undergoing IVF/ICSI-ET.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Each patient will choose a sealed envelope containing randomization number either group A or B. Both participant and health provider will be blinded to patients grouping
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group receiving oestradiol tablets in addition to progesterone
Group A :Will receive 400mg progesterone in the form of vaginal or rectal suppositories in addition to estradiol valerate oral tablets in a dose of 4mg/day(2x2), for luteal phase support. Starting from the day of ovum pickup and for 14 days after embryo transfer.
Group B : Will receive a dose of 400mg progesterone in the form of vaginal or rectal suppositories in addition to 2 placebo oral tablets(similar to estrogen tablets) for luteal phase support, from the day of Ovum pickup and for 14 days after embryo transfer.
Estradiol Valerate
Oestradiol supplementation starting from day of trigger through out the luteal phase
Group not receiving oestradiol tablets.
Group B : Will receive a dose of 400mg progesterone in the form of vaginal or rectal suppositories in addition to 2 placebo oral tablets(similar to estrogen tablets) for luteal phase support, from the day of Ovum pickup and for 14 days after embryo transfer
Estradiol Valerate
Oestradiol supplementation starting from day of trigger through out the luteal phase
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Estradiol Valerate
Oestradiol supplementation starting from day of trigger through out the luteal phase
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients Undergoing gonadotropin Releasing Hormone (Gn RH) long agonist protocol, with fresh embryo transfer.
3. Day 3 Grade 1 embryos.
4. Trilamellar endometrium with ranging endometrial thickness from 8 mm to 14 mm.
Exclusion Criteria
2. Patients with uterine abnormalities.
3. G3-G4 quality embryos.
4. Estradiol level 10,000 or more at time of trigger.
5. Cases of egg donation/sperm donation/embryo donation.
6. Polycystic ovary syndrome (PCOS )patients.
7. Poor responders (maternal age \>40, Antral follicle counts (AFC )\<5, Anti Mullerian Hormone (AMH )\<1 and previous trial \<5 oocyte retrieved ) (bologna criteria 2011)
8. Those with 3 or more implantation failure.
9. Endometrial thickness \<8 or \>14mm.
10. Severe male factor.
20 Years
38 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
sherine Hosny Mohamed Gad Allah
Assistant professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Art Unit/ Obatetrics and Gynecology Department
Cairo, Cair0, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sherine H Hosny
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD IVF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.