Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes

NCT06410417 | Recruiting DMC

• 1 other identifier: 2024-HS-035
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology. The main questions it aims to answer are: Does reducing the duration of ejaculation abstinence improve the clinical pregnancy rate for in vitro fertilization and intracytoplasmic sperm injection? Does reducing the duration of ejaculation abstinence improve embryo quality in in vitro fertilization and intracytoplasmic sperm injection？ Does reducing the duration of ejaculation abstinence affect pregnancy loss and live birth rates in in vitro fertilization and intracytoplasmic sperm injection? Researchers will compare less than 48 hours of abstinence time to more than 48 hours, to see if less than 48 hours of abstinence time improved in vitro fertilization outcomes Participants will: Control group abstinence for 3-7 days The experimental group ejaculated once on human chorionic gonadotropin trigger day Follow up their in vitro fertilization outcomes

Conditions

Fertilization in Vitro

Keywords

in vitro fertilization; intracytoplasmic sperm injection; Abstinence time; Clinical pregnancy rate; Embryo quality

Outcome Measures

Primary Outcomes (3)

• The pregnancy rate of different abstinence periods in in vitro fertilization.

  All participants underwent ultrasound examination four weeks after embryo transfer. A gestational sac was considered a clinical pregnancy (+), while the absence of a gestational sac was considered a non-clinical pregnancy (-). Clinical pregnancy rate = (number of clinical pregnancy (+) cycles/transplant cycles) ×100%. The aim was to compare the difference in pregnancy rates between the two groups.

  A year

• The fertilization rate of different abstinence periods in in vitro fertilization.

  Fertilization rate = (number of fertilized eggs/number of eggs harvested) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in fertilization rate between the two groups.

  A year

• The high-quality embryo rate of different abstinence periods in in vitro fertilization.

  High-quality embryo rate = (number of high-quality embryos/number of normal fertilized cleavage embryos) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in high-quality embryo rate between the two groups.

  A year

Secondary Outcomes (2)

• The pregnancy loss rate of different abstinence periods in in vitro fertilization.

  1.5 years

• The live birth rates of different abstinence periods in in vitro fertilization.

  1.5 years

Study Arms (2)

Short abstinence time group

EXPERIMENTAL

abstinence time is less than 48 hours

Behavioral: Shorten abstinence time

routine abstinence time group

NO INTERVENTION

Abstinence for 3-7 days

Interventions

Shorten abstinence time BEHAVIORAL

In the experimental group, male ejaculates once on human chorionic gonadotropin trigger day, and can be ejaculated on the second day if ejaculates fail.

Short abstinence time group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The couple is between 20 and 45 years old, and the woman's body mass index is greater than 18.5 and less than 30kg/m2.
• Meet the indications of assisted reproductive technology, agree to use assisted reproductive technology to assist pregnancy and have entered the process.
• The male has normal ejaculation function and plans to provide a semen sample by masturbation method on the day of egg retrieval.

You may not qualify if:

• Couples with serious infections and major physical diseases, such as HIV.
• The use of testicular sperm for intracytoplasmic sperm injection, such as the azoospermia.
• The use of frozen sperm for assisted reproductive technology.
• Endometriosis, repeated implantation failure, etc.
• There are clear factors affecting semen parameters within 3 months before sperm extraction, including high temperature, contact with chemicals，radiation or drugs that affect sperm, etc.;Previous orchitis/epididymitis, cryptorchidism, receiving radiotherapy and chemotherapy treatment

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (19)

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Study Officials

• Yueying Zhu, Master

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueying Zhu, Master

CONTACT

13504308455; zhuyueying1974@jlu.edu.cn

Yang Yu, doctorate

CONTACT

13844000361; yuyang0351@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 13, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-04

Locations

CN (1)