Does a treatment for pelvic congestion syndrome affect future fertility? A study measuring hormone levels before and after ovarian vein embolization
| ISRCTN | ISRCTN17249800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17249800 |
| Sponsor | Başakşehir Çam and Sakura City Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 08/04/2026
- Registration date
- 09/04/2026
- Last edited
- 09/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Pelvic congestion syndrome is a condition that can cause long term pelvic pain in women. It is linked to abnormal blood flow in the pelvic veins. One common treatment is ovarian vein embolization. This is a minimally invasive procedure that blocks the problem veins. While this treatment can reduce pain, there is limited information about whether it affects future fertility. This study aims to find out whether ovarian vein embolization changes ovarian function by measuring levels of a hormone linked to fertility before and after treatment.
Who can participate?
Women aged between 21 years and 45 years who have been diagnosed with pelvic congestion syndrome and are suitable for ovarian vein embolization can take part. Women who have had previous ovarian surgery or removal of an ovary cannot participate.
What does the study involve?
Participants receive ovarian vein embolization as part of their usual medical care. Blood samples are taken before the procedure and again at 1 month and 6 months after treatment. These samples are used to measure a hormone called anti-Müllerian hormone, which gives information about ovarian reserve. Participants also attend follow up visits so doctors can check whether pelvic pain symptoms have improved.
What are the possible benefits and risks of participating?
Participants may benefit from improvement in pelvic pain following treatment. Taking part also helps improve understanding of how this treatment might affect fertility, which may help future patients. The risks are the same as for standard ovarian vein embolization and blood tests. These may include discomfort, bruising, or rare procedure related complications. No extra risks are expected from taking part in the study itself.
Where is the study run from?
The study is run from Başakşehir Çam and Sakura City Hospital in Istanbul, Türkiye.
When is the study starting and how long is it expected to run for?
April 2023 to August 2026.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ali Dablan, alidablan.dr@gmail.com
Contact information
Scientific, Public, Principal investigator
Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir
İSTANBUL
34488
Türkiye
 ORCID ID |
0000-0003-4198-4416 |
|---|---|
| Phone | +90 5389230101 |
| ali.dablan@saglik.gov.tr |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | Prospective evaluation of reproductive safety after ovarian vein embolization for pelvic congestion syndrome using anti-Müllerian hormone levels |
| Study objectives | Primary objective: To evaluate the effect of ovarian vein embolization on ovarian reserve by comparing serum anti-Müllerian hormone (AMH) levels at baseline (pre-procedure) and at 1 and 6 months after the procedure in patients with pelvic congestion syndrome. Secondary objectives: To assess clinical symptom improvement following treatment and to explore the relationship between changes in AMH levels and clinical outcomes. |
| Ethics approval(s) |
Approved 05/04/2023, Ethics Committee of Başakşehir Çam and Sakura City Hospital (Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir, İSTANBUL, 34488, Türkiye; +90 212 909 60 00; basaksehircamsakuraetikkurul@gmail.com), ref: 153 |
| Health condition(s) or problem(s) studied | Pelvic congestion syndrome (chronic pelvic pain of venous origin) |
| Intervention | All patients underwent ovarian vein embolization for the treatment of pelvic congestion syndrome using standard interventional radiology techniques. The procedure was performed via femoral venous access with selective catheterization of the ovarian veins. Embolization was achieved using a combination of sclerotherapy, coil embolization, and liquid embolic agents (n-butyl cyanoacrylate–Lipiodol mixture) according to procedural requirements. Serum anti-Müllerian hormone (AMH) levels were measured prior to the procedure and at 1-month and 6-month follow-up. Clinical evaluation was also performed to assess symptom improvement after treatment. All data were collected prospectively using a standardized protocol. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 03/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 24 |
| Total final enrolment | 24 |
| Key inclusion criteria | Female patients aged 21–45 years with a diagnosis of pelvic congestion syndrome and an established indication for ovarian vein embolization |
| Key exclusion criteria | 1. History of ovarian surgery 2. Prior oophorectomy 3. Age outside 21–45 years |
| Date of first enrolment | 06/04/2023 |
| Date of final enrolment | 02/02/2026 |
Locations
Countries of recruitment
- Türkiye
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
09/04/2026: Trial's existence confirmed by Ethics Committee of Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye.
