Ovarian Function With ENG Implant and UPA Use
brief summary
Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 people capable of pregnancy desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.
detailed description
Primary Objectives:
1. To determine point estimates for the incidence of ovulation within five days of oral ulipristal acetate (UPA) administration with same day etonogestrel (ENG) implant insertion in the presence of a dominant follicle. 2. To determine point estimates for the incidence of ovulation within five days of etonogestrel (ENG) implant insertion alone in the presence of a dominant follicle.
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Clinical hypotheses:
• Combined oral UPA administration with same day ENG implant insertion will interfere with UPA's effect in delaying ovulation as occurs with oral progestogens given within 1-2 days of UPA.
Study Design: Pilot randomized, single site clinical trial with blinded analysis
Participant recruitment and study site: The investigators will recruit participants interested in using the ENG contraceptive implant but not currently at risk for pregnancy from Planned Parenthood Association of Utah clinics, University of Utah Hospital and Community clinics, and through targeted social media ads. All study procedures will occur at the University of Utah Hospital Outpatient OBGYN Clinic or at the University Center for Reproductive Medicine clinic.
Sample size: This is a pilot proposal to recruit a total of 40 participants across 2 study arms: (1) ENG implant only (n=20) and (2) UPA + same day ENG implant insertion (n=20). The investigators null hypotheses are:
1. ENG implant along with UPA administration in the presence of a dominant ovarian follicle will not change the expected 97% ovulation suppression within 5 days of UPA use. 2. ENG implant insertion alone in the presence of a dominant ovarian follicle will not sufficiently interrupt ovulation.
Randomization scheme: block randomization with block size of 4
Blinding protocol: This study will not be blinded as a pilot. The feasibility of the study, including clinic space limitations and provider time, relies on the same healthcare provider for implant insertion and ultrasound in many patients. All statistical analyses will be blinded to the statistician.
Participant procedures:
official title
A Pilot Prospective, Randomized Pharmacodynamic Study With Assessment of Ulipristal Acetate on Ovarian Activity Following Quickstart of the Etonogestrel Contraceptive Implant