Delayed Embryo Transfer in Poor Responders

NCT02431689 | Completed DMC

• 1 other identifier: 32015
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the current study the investigators will attempt to compare antagonist and short protocols regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still implantation and pregnancy rates are considered secondary outcomes.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Number of Metaphase II (MII) oocytes

  Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)

  9-14 days from stimulation

• Number of good embryos

  the number of good quality embryos obtained from each patient

  3-5 days after ovum pickup

Secondary Outcomes (6)

• chemical pregnancy rate

  14 days after embryo transfer

• clinical pregnancy rate

  5 weeks after embryo transfer

• Implantation rate

  5 weeks after embryo transfer

• Early miscarriage rate

  3 months

• Ongoing pregnancy rate

  3 months

Study Arms (2)

Antagonist

ACTIVE COMPARATOR

Antagonist protocol (fixed) for IVF/ICSI, with starting dose of human menopausal gonadotrophins (HMG) from 300-450 IU from day 1 of the cycle, antagonist start from day 6 stimulation. Follow-up by ultrasound and serum estradiol will be done. Triggering of ovulation using human chorionic gonadotrophin (HCG) 10000 IU I.M. when at least 2-3 follicles reach 17mm in diameter. Cryopreservation of all embryos at will be done. Frozen embryo transfer in the following cycle will be attempted using estradiol valerate (6mg) for endometrial preparation after pituitary down regulation using long acting GnRH analogue . A maximum of 3 good quality embryos will be transferred.

Procedure: IVF/ICSI

Short

ACTIVE COMPARATOR

Short protocol for IVF/ICSI, gonadotrophin releasing hormone analogue (GnRHa) starts from day 1 of the cycle, HMG starts in a dose from 300-450 IU from day 3, Follow-up by ultrasound and serum estradiol will be done. Triggering of ovulation using human chorionic gonadotrophin (HCG) 10000 IU I.M. when at least 2-3 follicles reach 17mm in diameter. Cryopreservation of all embryos at will be done. Frozen embryo transfer in the following cycle will be attempted using estradiol valerate (6mg) for endometrial preparation after pituitary down regulation using long acting GnRH analogue . A maximum of 3 good quality embryos will be transferred.

Procedure: IVF/ICSI

Interventions

IVF/ICSI PROCEDURE

controlled ovarian hyperstimulation with various protocols, follow up till stimulated follicles measure from 18-20 mm, then ovum pickup followed by embryo transfer is done.

Antagonist; Short

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient selection is based on the ESHRE consensus group 2011 definition of poor ovarian response (POR) (Bologna criteria):
• At least two of the following three features must be present:
• Advanced maternal age (≥40 years) or any other risk factor for POR;
• A previous POR (≤3 oocytes with a conventional stimulation protocol);
• An abnormal ovarian reserve test (i.e. Antral follicle count (AFC) \<5-7 follicles or Antimullerian hormone (AMH) \<0.5-1.1 ng/ml).
• Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal Ovarian reserve test (ORT). By definition, the term POR refers to the ovarian response and, therefore, one stimulated cycle is considered essential for the diagnosis of POR. However, patients over 40 years of age with an abnormal ORT may be classified as poor responders since both advanced age and an abnormal ORT may indicate reduced ovarian reserve and act as a surrogate of ovarian stimulation cycle. In this case, the patients should be more properly defined as expected PORs.

You may not qualify if:

• Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.

Sponsors & Collaborators

• Cairo University: lead
• Nile Ivf Center, Cairo, Egypt: collaborator
• Kamal Shaeer center of infertility: collaborator

Study Sites (3)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, 12311, Egypt

Location

Kamal Shaeer center of infertility

Giza, 12411, Egypt

Location

Nile IVF center

Giza, 12411, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Iman K Shaeer, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)