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Delayed Embryo Transfer in Poor Responders

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02431689
Enrollment
400
Registered
2015-05-01
Start date
2015-04-30
Completion date
2018-05-31
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

PROCEDUREIVF/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.

Sponsors

Nile Ivf Center, Cairo, Egypt
CollaboratorOTHER
Kamal Shaeer center of infertility
CollaboratorUNKNOWN
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Metaphase II (MII) oocytes9-14 days from stimulationNumber of MII oocytes collected from each patient on the day of ovum pickup (OPU)
Number of good embryos3-5 days after ovum pickupthe number of good quality embryos obtained from each patient

Secondary

MeasureTime frameDescription
Implantation rate5 weeks after embryo transferthe ratio between the number of embryos transferred and the number of sacs
Early miscarriage rate3 monthsPregnancy loss in the first 12 weeks gestation
chemical pregnancy rate14 days after embryo transferpositive serum Beta HCG 14 days after embryo transfer
Live birth rate9 monthsPregnancy ending with a live birth
Ongoing pregnancy rate3 monthsPregnancy ongoing beyond 12 weeks gestation
clinical pregnancy rate5 weeks after embryo transferthe detection of intrauterine gestational sac with positive pulsations

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026