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

ICSI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788681
• Other study ID #: Ain Shams Univ
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: Radwa R Ali, MD
• Phone: 01283492979
• Email: radwaebed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• ICSI

Intervention

Drug:
• Estradiol Valerate
oral estradiol " estradiol valerate " (Cyclo-Progynova)
• Placebo Oral Tablet
placebo

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo	Abbassya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	the number of deliveries that resulted in a live born neonate	at least 28 weeks after ET