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Delayed Embryo Transfer in Poor Responders

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IVF/ICSI
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
  • Kamal Shaeer center of infertility
  • Nile IVF center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antagonist

Short

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Metaphase II (MII) oocytes
Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)
Number of good embryos
the number of good quality embryos obtained from each patient

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2015
Last Updated
May 12, 2018
Sponsor
Cairo University
Collaborators
Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility
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1. Study Identification

Unique Protocol Identification Number
NCT02431689
Brief Title
Delayed Embryo Transfer in Poor Responders
Official Title
Antagonist and Short Protocols in Invitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) Cycles With Delayed Embryo Transfer in Poor Ovarian Response
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antagonist
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Short
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
IVF/ICSI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Metaphase II (MII) oocytes
Description
Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)
Time Frame
9-14 days from stimulation
Title
Number of good embryos
Description
the number of good quality embryos obtained from each patient
Time Frame
3-5 days after ovum pickup
Secondary Outcome Measure Information:
Title
chemical pregnancy rate
Description
positive serum Beta HCG 14 days after embryo transfer
Time Frame
14 days after embryo transfer
Title
clinical pregnancy rate
Description
the detection of intrauterine gestational sac with positive pulsations
Time Frame
5 weeks after embryo transfer
Title
Implantation rate
Description
the ratio between the number of embryos transferred and the number of sacs
Time Frame
5 weeks after embryo transfer
Title
Early miscarriage rate
Description
Pregnancy loss in the first 12 weeks gestation
Time Frame
3 months
Title
Ongoing pregnancy rate
Description
Pregnancy ongoing beyond 12 weeks gestation
Time Frame
3 months
Title
Live birth rate
Description
Pregnancy ending with a live birth
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. Exclusion Criteria: Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman K Shaeer, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
City
Cairo
ZIP/Postal Code
12311
Country
Egypt
Facility Name
Kamal Shaeer center of infertility
City
Giza
ZIP/Postal Code
12411
Country
Egypt
Facility Name
Nile IVF center
City
Giza
ZIP/Postal Code
12411
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Delayed Embryo Transfer in Poor Responders

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