Placental Development Pregnancy OutcomeNCT07843173
Peri-implantation Abstinence and Placental Health
A study testing Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period. in people with Placental Development Pregnancy Outcome, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This study examined whether avoiding sexual intercourse during the time when a fertilized egg may attach to the uterus affects placental development and pregnancy outcomes. Couples who were trying to conceive naturally were assigned by chance to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placental Development Pregnancy Outcome
- What is being tested?
- Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2021to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 20 to 40 years
- Attempting to conceive naturally
- Regular menstrual cycles of 28 to 30 days
- No history of major medical or gynecological disorders
- Willingness of both partners to provide written informed consent and follow the assigned study procedures
Who cannot join
- Polycystic ovary syndrome
- Endometriosis
- Current or previous tobacco use
- Current or previous alcohol use
- Body mass index below 18.5 or above 30 kg/m²
- Cardiovascular disease
Show all 14Show fewer
- Chronic hypertension
- Chronic respiratory disease
- Chronic renal disease
- Diabetes mellitus
- Previous pre-eclampsia
- Previous lower-segment cesarean section
- Previous dilatation and curettage
- Previous myomectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Peri-Implantation Sexual Abstinence on Placentation and Its Outcomes
This study examined whether avoiding sexual intercourse during the time when a fertilized egg may attach to the uterus affects placental development and pregnancy outcomes. Couples who were trying to conceive naturally were assigned by chance to one of two groups. Couples in the abstinence group were asked to avoid sexual intercourse for 14 days after ovulation. Couples in the no-restriction group continued their usual sexual activity without a study-imposed restriction. Participants were followed to determine whether pregnancy occurred and, when applicable, through pregnancy and delivery. During pregnancy, ultrasound was used to assess blood flow between the pregnant participant, placenta, and fetus. After delivery, available placentas were examined for tissue changes, blood-vessel development, and markers of oxidative stress, which reflects the balance between potentially damaging oxidants and the body's antioxidant defenses. Pregnancy and birth outcomes were also recorded. The study was designed to improve understanding of whether sexual activity around the time of implantation may be associated with placental development and pregnancy outcomes.
- Conditions
- Placental Development Pregnancy Outcome
- Being tested
- Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period.
- Keywords
- Sexual intercourse, Peri-implantation period Sexual abstinence, Placenta, Placental Development, Placental angiogenesis, Placentation, Natural conception, Placental oxidative stress, Placental histopathology
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period.Behavioural
Couples assigned to the intervention were instructed to avoid vaginal sexual intercourse for 14 consecutive days after ovulation during each study cycle. Ovulation timing was identified using the method specified in the study protocol. The restriction covered the expected peri-implantation period. After the 14-day abstinence period, no further study-imposed restriction on sexual activity was applied
| Study group | Role | What they receive |
|---|---|---|
| Abstinence | Experimental | Couples assigned to this arm were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle. The abstinence period covered the expected peri-implantation window. Receives: Behavioral: Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental Malondialdehyde Concentration
Malondialdehyde concentration was measured in placental tissue as an indicator of lipid peroxidation and normalized to total placental protein. The outcome was reported in nanomoles per milligram of protein.
Measured: At delivery
Placental Villous Microvessel Density Assessed by CD31 Immunohistochemistry
Placental villous microvessel density was measured as the mean number of CD31-positive microvessels per high-power field in placental tissue collected after delivery. CD31-positive structures were quantified using a prespecified QuPath-assisted digital image-analysis procedure by assessors blinded to study allocation.
Measured: At delivery
Placental Superoxide Dismutase Activity
Superoxide dismutase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein.
Measured: At delivery
Placental Catalase Activity
Catalase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein.
.
Measured: At delivery
Placental Total Antioxidant Capacity
Total antioxidant capacity was measured in placental tissue and normalized to total placental protein. The outcome was reported in micromoles per milligram of protein
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2021
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental Development Pregnancy OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abubakar Ibrahim, Universiti Sains Malaysia
- Investigators
- Nik Ahmad Zuky Nik Lah, Prof Obstetrics and gynecology, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843173
- Sponsor's protocol ID
- USM/JEPeM/21030234
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared publicly due to participant confidentiality and the conditions of the approved study consent and ethics framework. Aggregate and de-identified study results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peri-Implantation Sexual Abstinence on Placentation and Its Outcomes
- ClinicalTrials.gov ID
- NCT07843173
- Acronym / sponsor ID
- USM/JEPeM/21030234
- Conditions
- Placental Development Pregnancy Outcome
- Keywords
- Sexual intercourse, Peri-implantation period Sexual abstinence, Placenta, Placental Development, Placental angiogenesis, Placentation, Natural conception, Placental oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined whether avoiding sexual intercourse during the time when a fertilized egg may attach to the uterus affects placental development and pregnancy outcomes. Couples who were trying to conceive naturally were assigned by chance to one of two groups. Couples in the abstinence group were asked to avoid sexual intercourse for 14 days after ovulation. Couples in the no-restriction group continued their usual sexual activity without a study-imposed restriction. Participants were followed to determine whether pregnancy occurred and, when applicable, through pregnancy and delivery. During pregnancy, ultrasound was used to assess blood flow between the pregnant participant, placenta, and fetus. After delivery, available placentas were examined for tissue changes, blood-vessel development, and markers of oxidative stress, which reflects the balance between potentially damaging oxidants and the body's antioxidant defenses. Pregnancy and birth outcomes were also recorded. The study was designed to improve understanding of whether sexual activity around the time of implantation may be associated with placental development and pregnancy outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abstinence | Experimental | Behavioral: Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period.Couples assigned to this arm were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle. The abstinence period covered the expected peri-implantation window. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 20 to 40 years
- Attempting to conceive naturally
- Regular menstrual cycles of 28 to 30 days
- No history of major medical or gynecological disorders
- Willingness of both partners to provide written informed consent and follow the assigned study procedures
Key exclusion criteria (14 listed)
- Polycystic ovary syndrome
- Endometriosis
- Current or previous tobacco use
- Current or previous alcohol use
- Body mass index below 18.5 or above 30 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period.Couples assigned to the intervention were instructed to avoid vaginal sexual intercourse for 14 consecutive days after ovulation during each study cycle. Ovulation timing was identified using the method specified in the study protocol. The restriction covered the expected peri-implantation period. After the 14-day abstinence period, no further study-imposed restriction on sexual activity was applied | Behavioural | Abstinence |
Primary outcome
Placental Malondialdehyde Concentration
Time frame: At delivery
Malondialdehyde concentration was measured in placental tissue as an indicator of lipid peroxidation and normalized to total placental protein. The outcome was reported in nanomoles per milligram of protein.
Placental Villous Microvessel Density Assessed by CD31 Immunohistochemistry
Time frame: At delivery
Placental villous microvessel density was measured as the mean number of CD31-positive microvessels per high-power field in placental tissue collected after delivery. CD31-positive structures were quantified using a prespecified QuPath-assisted digital image-analysis procedure by assessors blinded to study allocation.
Placental Superoxide Dismutase Activity
Time frame: At delivery
Superoxide dismutase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein.
Placental Catalase Activity
Time frame: At delivery
Catalase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein. .
Placental Total Antioxidant Capacity
Time frame: At delivery
Total antioxidant capacity was measured in placental tissue and normalized to total placental protein. The outcome was reported in micromoles per milligram of protein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be shared publicly due to participant confidentiality and the conditions of the approved study consent and ethics framework. Aggregate and de-identified study results will be reported in scientific publications.
Related trials for Placental Development Pregnancy Outcome
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nik Ahmad Zuky Nik Lah, Prof Obstetrics and gynecology study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period. in people with Placental Development Pregnancy Outcome, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental Malondialdehyde Concentration (time frame: At delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.