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

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: ICSI

Treatments: Drug: Placebo Oral Tablet; Drug: Estradiol Valerate

Study type: Interventional

Funder types: Other

Identifiers

NCT03788681

Ain Shams Univ

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 35 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups, including a placebo group

oral estradiol " estradiol valerate

Active Comparator group

Description:

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.

Treatment:

Drug: Estradiol Valerate

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet