The aim of this study is to assess the relationship between the AGD, the 2D:4D ratio and the presence of MRKH syndrome, endometriosis and PCOS.
ID
Source
Brief title
Condition
- Reproductive tract and breast disorders congenital
- Congenital reproductive tract and breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the AGDac in all 4 groups.
Secondary outcome
Secondary study outcomes are:
- the difference in AGDaf and 2D:4D ratio in the four different patient groups
(MRKH vs. PCOS vs. endometriosis vs. controls)
The following parameters will also be monitored: age, ethnicity, BMI, medical
history, signs of clinical hyperandrogenism (by questionnaire) and ovarian
morphology by ultrasound.
Background summary
Mayer Rokitansky Küster Hauser (MRKH) syndrome is a congenital disorder,
characterized by aplasia of the uterus and the upper two thirds of the vagina.
The aetiology is unknown. We hypothesize that prenatal exposure to androgens is
responsible for the development of MRKH in the female. The anogenital distance
(AGD) and the ratio between the length of the 2nd and 4th digit (2D:4D ratio)
have been described as biomarkers of prenatal androgen exposure. In women with
polycystic ovary syndrome (PCOS) longer AGD is reported, suggesting that the
origin of PCOS is possibly due to prenatal exposure to androgens. In women with
severe endometriosis a decreased AGD has been reported, possibly due to
oestrogenic intrauterine influence.
We want to study the biomarkers AGD and 2D4Dratio in this 3 gynaecological
disorders, to study possible intrauterine exposure to hormones. (PCOS/MRK
andrenic exposure: longer AGD en lower 2D4D ratio, endometriosis oestrogenic
exposure: shorter AGD and higher 2D4D ratio)
Study objective
The aim of this study is to assess the relationship between the AGD, the 2D:4D
ratio and the presence of MRKH syndrome, endometriosis and PCOS.
Study design
Observational case control study.
Study burden and risks
This is a non-therapeutic study. In the course of this study we ask the
subjects for one visit to the outpatient clinic for measurements of AGD and
2D:4D ratio.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
MRKH group (43 patients)
- Diagnosed with MRKH syndrome
- Age * 18 years
- signed informed consent ;PCOS group:(43 patients)
- Diagnosed with PCOS
- Age * 18 years
- signed informed consent ;endometriosis group: (43 patients)
- Diagnosed with moderate-severe endometriosis
- Age * 18 years
- signed informed consent ;Control group: (43 patients)
- Age * 18 years
- Regular, ovulatory cycle
- ICSI treatment for male infertility
- signed informed consent
Exclusion criteria
MRKH women
- not willing to participate in the study
PCOS group:
- vaginal delivery in the medical history
- diagnosed with endometriosis
- not willing or able to sign the informed consent;Endometriosis group:
- vaginal delivery in the medical history
- diagnosed with PCOS
- not willing or able to sign the informed consent;Control group:
- diagnosed with PCOS/endometriosis
- ICSI treatment after a total fertilization failure in IVF cycle
- vaginal delivery in the medical history
- not willing or able to sign the informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64437.029.18 |
| OMON | NL-OMON23108 |