Is it useful to continue administration of gonadotropin releasing hormone (GnRH) agonist after embryo transfer?
| ISRCTN | ISRCTN13123887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13123887 |
| Protocol serial number | N/A |
| Sponsor | The Egyptian IVF Center (Egypt) |
| Funder | The Egyptian IVF Center (Egypt) |
- 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
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
Scientific
10 Geziret El Arab St.
Mohandessin
Cairo
12411
Egypt
| gharmd@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center prospective randomized study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
Ongoing pregnancy rate, which is diagnosed by ultrasound examination at 2024 weeks pregnancy to document a viable pregnancy at this point |
| Completion date | 28/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
12411
Egypt
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
