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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03788681

Enrollment

170

Registered

2018-12-27

Start date

2018-04-01

Completion date

2019-09-01

Last updated

2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICSI

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.

Interventions

DRUGEstradiol Valerate

oral estradiol estradiol valerate (Cyclo-Progynova)

DRUGPlacebo Oral Tablet

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 44 Years

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

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactRadwa R Ali, MD

radwaebed@yahoo.com01283492979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026