Clinical trial NCT06134609: Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?
Official title: Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Embryo Transfer
Fertilization in Vitro
Coitus
Keywords: IVF
Embryo Transfer
Sexual intercourse
Coitus
Pregnancy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 656
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, clinical trial. Patients will be randomized into two groups (by concealed envelopes). The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test whether sexual intercourse the night after embryo transfer affects thawed embryo implantation rates. Women undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group will abstain from intercourse for the next 48 hours after the transfer. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.

Detailed description: It is currently unclear whether sexual intercourse the night after embryo transfer, with or without semen ejaculation, is detrimental to thawed embryo implantation rates.

The following study is a prospective, randomized, clinical trial, including patients attending our university-affiliated Infertility and IVF center.

The goal of this clinical trial is to test whether coitus the night after embryo transfer affects thawed embryo implantation rates. At the day of the embryo transfer women (ages 18-41yrs) undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.

The day after the embryo transfer an electronic questionnaire will be sent to the patients to confirm whether they had intercourse or not. The questionnaire will also address whether male ejaculation was performed intravaginally and whether female orgasm occurred.

12-14 days after the embryo transfer a BHCG serum test will be performed. For those patients with a negative BHCG test surveillance will be stopped. For those with a positive BCHG test a gynecologic US will be performed at week 6. After wards surveillance will cease for all participants. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.

Eligibility criteria: Inclusion Criteria:

1. Women age 18-41yrs.
2. BMI (body mass index) of 18-35 kg/m².
3. Patients undergoing one of their first four frozen embryo transfers.
4. Patients transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst.

Exclusion Criteria:

1. Patients age above 42.
2. Moderate or poor-quality embryos.
3. Patients with hydrosalpinx or uterus malformations.
4. Patients who are not able or are not interested in having vaginal intercourse (same sex couples for example).
5. Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned (as they are instructed to avoid intercourse).

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: At 6 week of gestation (4 weeks after embryo transfer)
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 12-14 days after the embryo transfer
measure: Clinical pregnancy rate
timeFrame: At 6 week of gestation (4 weeks after embryo transfer)
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
citation: Crawford G, Ray A, Gudi A, Shah A, Homburg R. The role of seminal plasma for improved outcomes during in vitro fertilization treatment: review of the literature and meta-analysis. Hum Reprod Update. 2015 Mar-Apr;21(2):275-84. doi: 10.1093/humupd/dmu052. Epub 2014 Oct 3.
citation: Robertson SA, Sharkey DJ. Seminal fluid and fertility in women. Fertil Steril. 2016 Sep 1;106(3):511-9. doi: 10.1016/j.fertnstert.2016.07.1101. Epub 2016 Jul 30.
citation: Fanchin R, Righini C, Olivennes F, Taylor S, de Ziegler D, Frydman R. Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization. Hum Reprod. 1998 Jul;13(7):1968-74. doi: 10.1093/humrep/13.7.1968.
citation: Saccone G, Di Spiezio Sardo A, Ciardulli A, Caissutti C, Spinelli M, Surbek D, von Wolff M. Effectiveness of seminal plasma in in vitro fertilisation treatment: a systematic review and meta-analysis. BJOG. 2019 Jan;126(2):220-225. doi: 10.1111/1471-0528.15004. Epub 2017 Dec 6.
citation: Hou JW, Yuan LH, Cao XL, Song JY, Sun ZG. Impact of sexual intercourse on frozen-thawed embryo transfer outcomes: a randomized controlled trial. Contracept Reprod Med. 2023 Mar 2;8(1):19. doi: 10.1186/s40834-023-00218-y.