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Trial record 4 of 2074 for:    ESTRADIOL

Oestradiol Supplementation in Luteal Long Agonist Fresh In Vitro Fertilization/Intra Cytoplasmic Sperm Injection ( IVF/ICSI) Cycle .

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ClinicalTrials.gov Identifier: NCT03832894
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
sherine Hosny Mohamed Gad Allah, Cairo University

Brief Summary:
Whether oestradiol administration affects the pregnancy rate in long agonist fresh IVF/ICSI cycles. Oestradiol level will be measured the day of HCG trigger to assess whether oestradiol level affects cycle outcome results.

Condition or disease Intervention/treatment Phase
Infertility Drug: Estradiol Valerate Phase 3

Detailed Description:

6. Background and Rationale: Progesterone is essential for successful implantation and maintenance of early pregnancy . Although the oestrogen is not essential, it is important to maintain the progesterone level during the pregnancy and promote the transformation of the endometrium from the secretory to proliferative phase.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Randomization will be held by using the computer generated randomization codes, which will then be placed in the sealed envelopes by a third party (nurse).

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

Primary Purpose: Other
Official Title: Effects of Adding Oestradiol Supplementation in Luteal Phase in Patients Undergoing in Vitro Fertilization/ Intra Cytoplasmic Sperm Injection (IVF/ICSI ) Long Agonist Fresh Embryo Transfer Cycles
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020


Arm Intervention/treatment
Active Comparator: 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.

Drug: Estradiol Valerate
Oestradiol supplementation starting from day of trigger through out the luteal phase
Other Names:
  • Progynova
  • Progesterone vaginal suppositories

Placebo Comparator: 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
Drug: Estradiol Valerate
Oestradiol supplementation starting from day of trigger through out the luteal phase
Other Names:
  • Progynova
  • Progesterone vaginal suppositories




Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 4 weeks after embryo transfer of each enrolled patient ]
    Number of gestational sacs per number of embryos transferred per cycle


Secondary Outcome Measures :
  1. Chemical pregnancy rate [ Time Frame: Two weeks after embryo transfer of each enrolled patient ]
    Quantitative Beta Human Chorionic Gonadotropin (BHCG)

  2. Clinical pregnancy rate [ Time Frame: 4 weeks after embryo transfer of each enrolled patient with positive pregnancy test or 6 weeks from IVF cycle beginning in pregnant patients ]
    Intrauterine gestational sac with fetal pole with positive pulsation

  3. Ongoing pregnancy rate [ Time Frame: 10 weeks after embryo transfer of each enrolled patient or 12 weeks from starting IVF cycle in pregnant patients ]
    12 weeks gestation and more



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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age group 20-38 years old.
  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:

  1. Karyotypic abnormalities in either partner.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832894


Contacts
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Contact: SHERINE HOSNY 01097665573 sherinehosny@gmail.com

Locations
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Egypt
Art Unit/ Obatetrics and Gynecology Department Recruiting
Cairo, Cair0, Egypt, 11542
Contact: Sherine H Hosny    01097665573      
Sponsors and Collaborators
Cairo University

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Responsible Party: sherine Hosny Mohamed Gad Allah, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03832894     History of Changes
Other Study ID Numbers: MD IVF
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by sherine Hosny Mohamed Gad Allah, Cairo University:
IVF
ICSI
oestradiol
long protocol
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins