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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned to intercourse | Experimental | The study group is subjected to perform intercourse without using a condom at the evening/night after the embryo transfer |
|
| Assigned to abstain | No Intervention | The control group is assigned to abstain from coitus the next 48 hours after the embryo transfer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sexual intercourse | Behavioral | Sexual intercourse without barrier contraceptive at the evening/night after the embryo transfer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Ultrasound showing a fetus with a heartbeat | At 6 week of gestation (4 weeks after embryo transfer) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy rate | Positive BHCG blood test | 12-14 days after the embryo transfer |
| Clinical pregnancy rate | Ultrasound confirmation of an intrauterine gestational sac |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25281684 | Background | 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. | |
| 27485480 | Background | 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. |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012723 | Sex |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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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.
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| At 6 week of gestation (4 weeks after embryo transfer) |
| 9740459 | Background | 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. |
| 29078039 | Background | 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. |
| 36859338 | Background | 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. |