Freeze-all Policy in Poor Responders

Infertility, Female Clinical Trial

Official title:

Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03999541
• Other study ID #: #0014
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2020
• Source: Al-Yasmeen Fertility and Gynecology Center
• Contact: Yasmin Magdi, PhD
• Phone: 00201282313979
• Email: Yas.magdi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Egypt	Al-Yasmeen Fertility and Gynecology Center	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Al-Yasmeen Fertility and Gynecology Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Livebirth rate	The proportion of women in the population who had at least one live baby.	32 weeks
Secondary	Pregnancy rate	Positive pregnancy test at two weeks +/- three days after embryo transfer	2 weeks
Secondary	Clinical pregnancy rate	The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation	6-8 weeks