AMH and Pregnancy Outcome in IVF

AMH Clinical Trial

Official title:

Low Anti-mullerian Hormone and Pregnancy Outcome in IVF

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04512807
• Other study ID #: Dr. Atyaf Aldawodi
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• AMH

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