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

NCT ID: NCT03788681

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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ICSI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Estradiol Valerate

Intervention Type DRUG

oral estradiol " estradiol valerate " (Cyclo-Progynova)

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

placebo

Interventions

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Estradiol Valerate

oral estradiol " estradiol valerate " (Cyclo-Progynova)

Intervention Type DRUG

Placebo Oral Tablet

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Radwa Rasheedy Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AinShams university maternity hospital

Cairo, Abbassya, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Radwa R Ali, MD

Role: CONTACT

Phone: 01283492979

Email: [email protected]

Facility Contacts

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Mostafa f Gomaa, MD

Role: primary

Other Identifiers

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Ain Shams Univ

Identifier Type: -

Identifier Source: org_study_id