Delayed Embryo Transfer in Poor Responders

Infertility Clinical Trial

Official title:

Antagonist and Short Protocols in Invitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) Cycles With Delayed Embryo Transfer in Poor Ovarian Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431689
• Other study ID #: 32015
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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:

1. Advanced maternal age (=40 years) or any other risk factor for POR;

2. A previous POR (=3 oocytes with a conventional stimulation protocol);

3. 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• IVF/ICSI
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.

Locations

Country	Name	City	State
Egypt	IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)	Cairo
Egypt	Kamal Shaeer center of infertility	Giza
Egypt	Nile IVF center	Giza

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Kamal Shaeer center of infertility, Nile Ivf Center, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of good embryos	the number of good quality embryos obtained from each patient	3-5 days after ovum pickup
Secondary	chemical pregnancy rate	positive serum Beta HCG 14 days after embryo transfer	14 days after embryo transfer
Secondary	clinical pregnancy rate	the detection of intrauterine gestational sac with positive pulsations	5 weeks after embryo transfer
Secondary	Implantation rate	the ratio between the number of embryos transferred and the number of sacs	5 weeks after embryo transfer
Secondary	Early miscarriage rate	Pregnancy loss in the first 12 weeks gestation	3 months
Secondary	Ongoing pregnancy rate	Pregnancy ongoing beyond 12 weeks gestation	3 months
Secondary	Live birth rate	Pregnancy ending with a live birth	9 months