Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
Study NCT ID:
NCT07274202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Physical and Mental Impact of ART: IVM vs Conventional Ovarian Stimulation
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
The Physical and Mental Impact of ART: an RCT Comparing IVM and Conventional Ovarian Stimulation From a Patient Perspective
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QolART
Brief Summary:
Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine conditions, affecting around 10% of women in reproductive age (ESHRE PCOS guideline, 2023).
PCOS is a heterogeneous condition characterized by a combination of Polycystic Ovarian Morphology (PCOM) on ultrasound scan, oligo- or amenorrhea and/or hyperandrogenism. Women diagnosed with PCOS are known to have a higher risk for type 2 diabetes mellitus, cardiovascular pathology, pregnancy complications and an impaired quality of life (QoL) (Borghi et al., 2017; ESHRE guideline, 2023). Conventional Ovarian Stimulation (cOS) followed by in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) is the most frequently used type of ART for PCOS patients. However, women with PCOS often exhibit ovarian hyperresponse to conventional-dose gonadotropin stimulation/cOS, with ovarian hyperstimulation syndrome (OHSS) as the most frequently occurring iatrogenic complication (Vesztergom et al., 2021 ; ESHRE PCOS guideline, 2023). Although, due to a number of strategies to prevent OHSS, the occurrence of severe OHSS has almost been eliminated, with the use of GnRH agonists for final oocyte maturation instead of an hCG trigger as the most efficient strategy, patients might still experience symptoms of abdominal pain and bloating as an indication for mild or moderate OHSS (Bodri et al., 2010 ; Shrem et al., 2019). Aside from the risk for OHSS, patients undergoing cOS, which represents on average a two-week hormonal treatment, may also experience symptoms of hot flushes, breast tenderness, mood swings and higher psychological burden resulting in a reduced QoL during fertility treatment (Barrière et al., 2019; Shrem et al., 2019 ; Adeleye et al., 2020).
In view of the aforementioned inconveniences of cOS, In Vitro Maturation of oocytes (IVM) followed by ICSI has been proposed as an alternative treatment option in a PCOS population (Trounson et al., 1994 ; ESHRE PCOS guideline, 2023). In Vitro Maturation has been labeled as a more 'patient-friendly' approach, with the ability to further eliminate the risk for OHSS, minimize cycle monitoring (resulting in less in-hospital visits) and reduced side-effects from hormonal ovarian stimulation (Gilchrist and Smitz, 2023; ESHRE PCOS guideline, 2023 ; Vuong et al., 2023). However, to the best of our knowledge, there is only limited research that investigated the prevalence and types of side-effects and the impact on pain scores and QoL of IVM treatment in PCOS patients (Sanmartin et al., under review; Marchante et al., 2024). Therefore, we set out to investigate the impact of IVM on pain scores, side-effects and QoL during fertility treatment in women diagnosed with severe PCOS. We defined severe PCOS as women with a serum AMH\>10ng/mL because we observed that above this cut-off, cumulative ongoing pregnancy rates were non-inferior after IVM compared to cOS (Mostinckx et al., 2024), with non-inferiority defined as a difference of less than 10% in cumulative ongoing pregnancy rate per cycle.
This trial is a single center, superiority, randomized controlled trial that will be conducted at Brussels IVF, UZ Brussel, Belgium in a PCOS population, presenting for their first round of ART at Brussels IVF. Each patient can only participate once in this trial.
64 patients are planned to be enrolled in the trial. 32 patients will be required in the control group (cOS group) and 32 patients in the interventional group (IVM group).
Patients will randomly undergo IVM or cOS following randomization. Both treatments will be executed as per treatment as usual (TAU). In both treatment arms, included patients and their partners, will be asked to complete questionnaires at different timepoints after randomization into one of the two treatment arms:
* At the time of counseling (T1)
* At the end of stimulation (T2)
* On the day of oocyte retrieval (T3)
* On the day after oocyte retrieval (T4)
* At 7 days after oocyte retrieval (T5)
* At the end of first embryo transfer cycle (T6)
* End of first ART cycle Used questionnaires are two validated questionnaires, FertiQoL and HADS, and a questionnaire developed to investigate side-effects and pain scores after oocyte retrieval.
PCOS is a heterogeneous condition characterized by a combination of Polycystic Ovarian Morphology (PCOM) on ultrasound scan, oligo- or amenorrhea and/or hyperandrogenism. Women diagnosed with PCOS are known to have a higher risk for type 2 diabetes mellitus, cardiovascular pathology, pregnancy complications and an impaired quality of life (QoL) (Borghi et al., 2017; ESHRE guideline, 2023). Conventional Ovarian Stimulation (cOS) followed by in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) is the most frequently used type of ART for PCOS patients. However, women with PCOS often exhibit ovarian hyperresponse to conventional-dose gonadotropin stimulation/cOS, with ovarian hyperstimulation syndrome (OHSS) as the most frequently occurring iatrogenic complication (Vesztergom et al., 2021 ; ESHRE PCOS guideline, 2023). Although, due to a number of strategies to prevent OHSS, the occurrence of severe OHSS has almost been eliminated, with the use of GnRH agonists for final oocyte maturation instead of an hCG trigger as the most efficient strategy, patients might still experience symptoms of abdominal pain and bloating as an indication for mild or moderate OHSS (Bodri et al., 2010 ; Shrem et al., 2019). Aside from the risk for OHSS, patients undergoing cOS, which represents on average a two-week hormonal treatment, may also experience symptoms of hot flushes, breast tenderness, mood swings and higher psychological burden resulting in a reduced QoL during fertility treatment (Barrière et al., 2019; Shrem et al., 2019 ; Adeleye et al., 2020).
In view of the aforementioned inconveniences of cOS, In Vitro Maturation of oocytes (IVM) followed by ICSI has been proposed as an alternative treatment option in a PCOS population (Trounson et al., 1994 ; ESHRE PCOS guideline, 2023). In Vitro Maturation has been labeled as a more 'patient-friendly' approach, with the ability to further eliminate the risk for OHSS, minimize cycle monitoring (resulting in less in-hospital visits) and reduced side-effects from hormonal ovarian stimulation (Gilchrist and Smitz, 2023; ESHRE PCOS guideline, 2023 ; Vuong et al., 2023). However, to the best of our knowledge, there is only limited research that investigated the prevalence and types of side-effects and the impact on pain scores and QoL of IVM treatment in PCOS patients (Sanmartin et al., under review; Marchante et al., 2024). Therefore, we set out to investigate the impact of IVM on pain scores, side-effects and QoL during fertility treatment in women diagnosed with severe PCOS. We defined severe PCOS as women with a serum AMH\>10ng/mL because we observed that above this cut-off, cumulative ongoing pregnancy rates were non-inferior after IVM compared to cOS (Mostinckx et al., 2024), with non-inferiority defined as a difference of less than 10% in cumulative ongoing pregnancy rate per cycle.
This trial is a single center, superiority, randomized controlled trial that will be conducted at Brussels IVF, UZ Brussel, Belgium in a PCOS population, presenting for their first round of ART at Brussels IVF. Each patient can only participate once in this trial.
64 patients are planned to be enrolled in the trial. 32 patients will be required in the control group (cOS group) and 32 patients in the interventional group (IVM group).
Patients will randomly undergo IVM or cOS following randomization. Both treatments will be executed as per treatment as usual (TAU). In both treatment arms, included patients and their partners, will be asked to complete questionnaires at different timepoints after randomization into one of the two treatment arms:
* At the time of counseling (T1)
* At the end of stimulation (T2)
* On the day of oocyte retrieval (T3)
* On the day after oocyte retrieval (T4)
* At 7 days after oocyte retrieval (T5)
* At the end of first embryo transfer cycle (T6)
* End of first ART cycle Used questionnaires are two validated questionnaires, FertiQoL and HADS, and a questionnaire developed to investigate side-effects and pain scores after oocyte retrieval.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: