Freeze-all Policy in Poor Responders

Not Applicable

• Conditions: Infertility, Female
• Interventions: Other: Freeze-all policy

• Registration Number: NCT03999541
• Lead Sponsor: Al-Yasmeen Fertility and Gynecology Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-22
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Study Start: 2019-07-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-25
• Last Update Posted: 2020-01-28
• Primary Completion: 2020-03-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 178

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freeze-all	Freeze-all policy	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.

Primary Outcome Measures

Name	Time	Method
Livebirth rate	32 weeks	The proportion of women in the population who had at least one live baby.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	2 weeks	Positive pregnancy test at two weeks +/- three days after embryo transfer
Clinical pregnancy rate	6-8 weeks	The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation

Trial Locations

Locations (1)

Al-Yasmeen Fertility and Gynecology Center; 🇪🇬 Banhā, Egypt