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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04512807
Other study ID # Dr. Atyaf Aldawodi
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 15, 2020
Est. completion date November 25, 2020

Study information

Verified date October 2020
Source Al Baraka Fertility Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 650
Est. completion date November 25, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years to 45 Years
Eligibility Inclusion Criteria: Women =22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol Exclusion Criteria: - Women = 45 years age - AMH >0.5 - Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis) - Endocrine dysfunction or organ dysfunction such as liver or kidney failure.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
AMH
AMH & PREGNANCY

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Al Baraka Fertility Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary pregnancy test B-HCG 2 weeks
Primary clinical pregnancy rate fetal heart activity 4 weeks
See also
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