Freeze-all Policy in Poor Responders

Sponsor
Al-Yasmeen Fertility and Gynecology Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03999541
Collaborator
(none)
178
1
2
17.1
10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Freeze-all policy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Blinding of the allocated intervention is not possible.
Primary Purpose:
Other
Official Title:
Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Actual Study Start Date :
Jul 30, 2019
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Freeze-all

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.

Other: Freeze-all policy
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer

No Intervention: Fresh embryo transfer

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

Outcome Measures

Primary Outcome Measures

  1. Livebirth rate [32 weeks]

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

Secondary Outcome Measures

  1. Pregnancy rate [2 weeks]

    Positive pregnancy test at two weeks +/- three days after embryo transfer

  2. Clinical pregnancy rate [6-8 weeks]

    The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-Yasmeen Fertility and Gynecology Center Banhā Egypt

Sponsors and Collaborators

  • Al-Yasmeen Fertility and Gynecology Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasmin Magdi, Director, Al-Yasmeen Fertility and Gynecology Center
ClinicalTrials.gov Identifier:
NCT03999541
Other Study ID Numbers:
  • #0014
First Posted:
Jun 26, 2019
Last Update Posted:
Jan 28, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2020