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Status unknownNCT03788681Updated Dec 27, 2018

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

A Phase 3 interventional study of Estradiol Valerate and Placebo Oral Tablet in ICSI, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 35 Years to 44 Years. Per ClinicalTrials.gov, last updated 2018-12-27.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2018, registered Dec 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
35 Years to 44 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • ICSI
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
170 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugEstradiol Valerate

    oral estradiol " estradiol valerate " (Cyclo-Progynova)

  • DrugPlacebo Oral Tablet

    placebo

06

What researchers measure

Primary outcomes

  1. live birth rate

    the number of deliveries that resulted in a live born neonate

    Time frame: at least 28 weeks after ET

07

Study locations

1 of 1 sites recruiting
  • AinShams university maternity hospital
    Cairo, Abbassya 11566, Egypt
    • Mostafa f Gomaa, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03788681
Lead sponsor
Ain Shams University
Responsible party
Radwa Rasheedy Ali (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Dec 27, 2018
Start date
Apr 1, 2018
Primary completion
Aug 1, 2019 (estimated)
Completion
Sep 1, 2019 (estimated)
Last update
Dec 27, 2018

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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