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

NCT03788681 | Unknown Phase 3

• 1 other identifier: Ain Shams Univ
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

ICSI

Outcome Measures

Primary Outcomes (1)

• live birth rate

  the number of deliveries that resulted in a live born neonate

  at least 28 weeks after ET

Study Arms (2)

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.

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

Drug: Placebo Oral Tablet

Interventions

Estradiol Valerate DRUG

oral estradiol " estradiol valerate " (Cyclo-Progynova)

oral estradiol " estradiol valerate

Placebo Oral Tablet DRUG

placebo

placebo

Eligibility Criteria

• Age: 35 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 :
• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979; radwaebed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 27, 2018
• Study Start: April 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

EG (1)