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Freeze-all Policy in Poor Responders

A

Al-Yasmeen Fertility and Gynecology Center

Status

Unknown

Conditions

Infertility, Female

Treatments

Other: Freeze-all policy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

178 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

178 participants in 2 patient groups

Freeze-all
Experimental group
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.
Treatment:
Other: Freeze-all policy
Fresh embryo transfer
No Intervention group
Description:
Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).

Trial contacts and locations

1

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Central trial contact

Yasmin Magdi, PhD

Data sourced from clinicaltrials.gov

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