Is it useful to continue administration of gonadotropin releasing hormone (GnRH) agonist after embryo transfer?

ISRCTN	ISRCTN13123887
DOI	https://doi.org/10.1186/ISRCTN13123887
Secondary identifying numbers	N/A

Submission date: 02/02/2014
Registration date: 20/02/2014
Last edited: 20/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Mohamed Aboulghar
Scientific

10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt

Email	gharmd@gmail.com

Study information

Study design	Single-center prospective randomized study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	The Committee of Ethics and Research of the Egyptian IVF Center, 01/06/2012
Health condition(s) or problem(s) studied	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
Primary outcome measure	Clinical pregnancy rate, which is measured by BhCG assay 2 weeks after embryo transfer followed by ultrasound at 67 weeks to detect fetal echoes and pulsation
Secondary outcome measures	Ongoing pregnancy rate, which is diagnosed by ultrasound examination at 2024 weeks pregnancy to document a viable pregnancy at this point
Overall study start date	01/07/2012
Completion date	28/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	446
Key inclusion criteria	Women under 40 years old undergoing intracytoplasmic sperm injection (ICSI) in the first or second trial and using the long GnRHa protocol
Key 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
Date of first enrolment	01/07/2012
Date of final enrolment	28/02/2014

Locations

Countries of recruitment

Egypt

Study participating centre

10 Geziret El Arab St.,

Cairo
12411
Egypt

Sponsor information

The Egyptian IVF Center (Egypt)
Hospital/treatment centre

3 St 161 Hadaek El Maadi
Cairo
11431
Egypt

Phone	+20 (0)2 2525 4944
Email	ivf@link.net
"ROR"	https://ror.org/035aahr55

Funders

Funder type

Hospital/treatment centre

The Egyptian IVF Center (Egypt)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan