Delayed Embryo Transfer in Poor Responders
- Conditions
- Infertility
- Interventions
- Procedure: IVF/ICSI
- Registration Number
- NCT02431689
- Lead Sponsor
- Cairo University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
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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.
- Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short IVF/ICSI 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. Antagonist IVF/ICSI 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.
- Primary Outcome Measures
Name Time Method Number of good embryos 3-5 days after ovum pickup the number of good quality embryos obtained from each patient
Number of Metaphase II (MII) oocytes 9-14 days from stimulation Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)
- Secondary Outcome Measures
Name Time Method chemical pregnancy rate 14 days after embryo transfer positive serum Beta HCG 14 days after embryo transfer
Ongoing pregnancy rate 3 months Pregnancy ongoing beyond 12 weeks gestation
clinical pregnancy rate 5 weeks after embryo transfer the detection of intrauterine gestational sac with positive pulsations
Implantation rate 5 weeks after embryo transfer the ratio between the number of embryos transferred and the number of sacs
Live birth rate 9 months Pregnancy ending with a live birth
Early miscarriage rate 3 months Pregnancy loss in the first 12 weeks gestation
Trial Locations
- Locations (3)
Nile IVF center
🇪🇬Giza, Egypt
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
🇪🇬Cairo, Egypt
Kamal Shaeer center of infertility
🇪🇬Giza, Egypt