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Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

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ClinicalTrials.gov Identifier: NCT03788681
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Brief 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 . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.

Condition or disease Intervention/treatment Phase
ICSI Drug: Estradiol Valerate Drug: Placebo Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

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Arm Intervention/treatment
Active Comparator: oral estradiol " estradiol valerate
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.
Drug: Estradiol Valerate
oral estradiol " estradiol valerate " (Cyclo-Progynova)

Placebo Comparator: placebo
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
Drug: Placebo Oral Tablet
placebo




Primary Outcome Measures :
  1. live birth rate [ Time Frame: at least 28 weeks after ET ]
    the number of deliveries that resulted in a live born neonate



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Ages Eligible for Study:   35 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants included in this study will have the following criteria : ( 2 of 3 criteria )

    1. advanced maternal age or any other risk factor for POR :

      1. Age ≥35 years
      2. other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
    2. previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
    3. Abnormal ovarian reserve tests :

      1. FSH ≥12 mIu/ml in the early follicular phase .
      2. Estradiol level more than 70 pg/dl in the early follicular phase
      3. Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
      4. Antral follicle count (AFC) < 5-7 follicles .

Exclusion Criteria:

  1. Age >35 with good ovarian response .
  2. any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
  3. Severe male factor infertility.
  4. Extended endometriosis (stage 3 or more) .
  5. All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer

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): NCT03788681


Contacts
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Contact: Radwa R Ali, MD 01283492979 ext 02002 radwaebed@yahoo.com

Locations
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Egypt
AinShams university maternity hospital Recruiting
Cairo, Abbassya, Egypt, 11566
Contact: Mostafa f Gomaa, MD         
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Radwa Rasheedy Ali, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03788681     History of Changes
Other Study ID Numbers: Ain Shams Univ
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female