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Freeze-all Policy in Poor Responders

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Freeze-all policy
Sponsored by
Al-Yasmeen Fertility and Gynecology Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility, Female

Eligibility Criteria

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

Inclusion Criteria:

  • All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
  • if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
  • body mass index 18-32 kg/m2
  • Both partners are able to provide written informed consent.
  • At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
  • Endometrial thickness ≥8 mm on trigger day.
  • a normal uterine cavity on ultrasound.
  • IVF/ICSI with only fresh semen

Exclusion Criteria:

  • Pre-implantation genetic testing is being planned.
  • if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.

Sites / Locations

  • Al-Yasmeen Fertility and Gynecology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Freeze-all

Fresh embryo transfer

Arm Description

Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival.

Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).

Outcomes

Primary Outcome Measures

Livebirth rate
The proportion of women in the population who had at least one live baby.

Secondary Outcome Measures

Pregnancy rate
Positive pregnancy test at two weeks +/- three days after embryo transfer
Clinical pregnancy rate
The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation

Full Information

First Posted
June 22, 2019
Last Updated
January 25, 2020
Sponsor
Al-Yasmeen Fertility and Gynecology Center
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1. Study Identification

Unique Protocol Identification Number
NCT03999541
Brief Title
Freeze-all Policy in Poor Responders
Official Title
Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Yasmeen Fertility and Gynecology Center

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
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Blinding of the allocated intervention is not possible.
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Freeze-all
Arm Type
Experimental
Arm Description
Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival.
Arm Title
Fresh embryo transfer
Arm Type
No Intervention
Arm Description
Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).
Intervention Type
Other
Intervention Name(s)
Freeze-all policy
Intervention Description
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
Primary Outcome Measure Information:
Title
Livebirth rate
Description
The proportion of women in the population who had at least one live baby.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Positive pregnancy test at two weeks +/- three days after embryo transfer
Time Frame
2 weeks
Title
Clinical pregnancy rate
Description
The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation
Time Frame
6-8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)] if the progesterone serum level was ≤1.5 ng/mL on the trigger day. body mass index 18-32 kg/m2 Both partners are able to provide written informed consent. At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume). Endometrial thickness ≥8 mm on trigger day. a normal uterine cavity on ultrasound. IVF/ICSI with only fresh semen Exclusion Criteria: Pre-implantation genetic testing is being planned. if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Magdi, PhD
Phone
00201282313979
Email
Yas.magdi@hotmail.com
Facility Information:
Facility Name
Al-Yasmeen Fertility and Gynecology Center
City
Banhā
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin Magdi, Ph.D
Phone
00201282313979
Email
Yas.magdi@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Freeze-all Policy in Poor Responders

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