Condition category
Pregnancy and Childbirth
Date applied
02/02/2014
Date assigned
20/02/2014
Last edited
20/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many clinical studies have tried to improve implantation and pregnancy rates after in vitro fertilisation (IVF) / intracytoplasmic sperm injection (ICSI) Many researchers think that the relatively low pregnancy rate in IVF and ICSI is due to a problem with the endometrium (lining of the uterus) in the luteal phase (the part of the menstrual cycle which begins immediately after ovulation). Estrogen was tried in addition to the standard progesterone treatment. However, no improvement was found by adding estrogen.
Several researchers tried to improve the implantation rate by giving gonadotropin releasing hormone agonist (GnRHa) injection in the luteal phase in different doses. The results of these studies are controversial. The aim of this study is to find out if there is evidence that administration of GnRHa during the period following embryo transfer will improve implantation and pregnancy rates.

Who can participate?
Any woman below the age of 40 years who was assigned to start IVF/ICSI treatment.

What does the study involve?
Participants were randomly allocated to one of two study groups.
The first group will receive GnRHa after the embryo transfer and the other group will not receive GnRHa.

What are the possible benefits and risks of participating?
There is a possible improvement of implantation and pregnancy rate. According to the previously published studies on this subject there are no risks to the patients and no possible reduction in the pregnancy rate.

Where is the study run from?
The Egyptian IVF Center (Egypt).

When is the study starting and how long is it expected to run for?
The study started in July 2012 and is expected to run until February 2014.

Who is funding the study?
Egyptian IVF Center (Egypt).

Who is the main contact?
Prof. Mohamed Aboulghar
gharmd@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mohamed Aboulghar

ORCID ID

Contact details

10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt
gharmd@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective randomized study evaluating the effect of administrating GnRH agonist (GnRHa) in the luteal phase on the outcome of ICSI cycles stimulated with long GnRHa protocols

Acronym

Study hypothesis

There are controversial data in the literature concerning the effect of continuation of GnRHa in the luteal phase on the pregnancy rate. This is a randomized study to evaluate the value of GnRHa administration in the luteal phase and to perform a meta-analysis with previous similar randomized studies to further strengthen the outcome of the results.

Ethics approval

The Committee of Ethics and Research of the Egyptian IVF Center, 01/06/2012

Study design

Single-center prospective randomized study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infertility treated by ICSI

Intervention

The number of patients included in both groups was chosen based upon a special statistical calculation which makes the outcome of the study meaningful. After the pre-calculated number is reached the study is declared finished and we will send data to a statistician to find out of administration of GnRHa in the luteal phase is useful and effective and accordingly we may advise patients to take or not take this medicine after embryo transfer routinely.

Participants are randomised to two arms:
1. GnRHa is injected in luteal phase plus the usual luteal phase support
2. The usual luteal phase support only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical pregnancy rate, which is measured by BhCG assay 2 weeks after embryo transfer followed by ultrasound at 6–7 weeks to detect fetal echoes and pulsation

Secondary outcome measures

Ongoing pregnancy rate, which is diagnosed by ultrasound examination at 20–24 weeks pregnancy to document a viable pregnancy at this point

Overall trial start date

01/07/2012

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Women under 40 years old undergoing intracytoplasmic sperm injection (ICSI) in the first or second trial and using the long GnRHa protocol

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

446

Participant exclusion criteria

1. Donor eggs
2. Patients aged 40 or older
3. Pre-implantation Genetic Diagnosis (PGD) cycles
4. Patients with fibroids or congenital anomalies of the uterus

Recruitment start date

01/07/2012

Recruitment end date

28/02/2014

Locations

Countries of recruitment

Egypt

Trial participating centre

10 Geziret El Arab St.,
Cairo
12411
Egypt

Sponsor information

Organisation

The Egyptian IVF Center (Egypt)

Sponsor details

3 St 161 Hadaek El Maadi
Cairo
11431
Egypt
+20 (0)2 2525 4944
ivf@link.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Egyptian IVF Center (Egypt)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes